MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-05-30 for ULTRATHANE SUPRAPUBIC CATHETER SET USCS-140025 manufactured by Cook Inc.
[109612143]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[109612144]
It was reported, while using a ultrathane suprapubic catheter set, during a supra pubic catheter placement it was difficult to verify if the loop catheter was in the bladder. The physician said he could not verify if the catheter was in the correct position in the bladder and the patient was taken to the or for an open placement. No additional patient consequences were reported. Additional information has been requested however,the customer has not provided any further information.
Patient Sequence No: 1, Text Type: D, B5
[120562152]
Evaluation / investigation: the actual complaint device was not returned. No photograph or imaging was provided for review. Without the complaint device, a physical investigation was not able to be completed. A document based investigation has been performed. A review of the instructions for use, and specifications was conducted. A review of the device history record could not be performed as the lot number of the device was not provided. A review of complaint history could not be performed on the complaint device lot because the lot number was not provided. It is not known if the physician filled the bladder with sterile saline prior to placement or if the bladder was not already distended by urine as instructed in instructions for use (ifu). There is no information regarding placement of the catheter. The ifu instructs to insert catheter vertically into the bladder on patients without previous pelvic surgery, or at a 30? Angle toward the symphysis pubis on patients with previous pelvic surgery. There is no information stating how placement was checked. Per the ifu, if bladder pressure is low and urine fails to flow spontaneously through the needle, aspirate urine to ascertain that the catheter tip is in the bladder. Advance the catheter no more than 4 to 5 cm beyond the first sign of bladder fluid. Once the catheter position has been confirmed, carefully remove the cannula assembly while gently advancing the catheter several more centimeters. The catheter must be well within the bladder to ensure proper formation of the retention loop. A document review identified that the device is shipped with the instructions for use which provides details on placement and specifically verification technique. Further information was requested from the medical professional involved, they responded by indicating they did not want to make this into a complaint and did not wish to share further information about the event. As the device was not returned and the lot number has not been provided, the device history record could not be reviewed and a product failure analysis could not be carried out. The user of the product had difficulty using the device, however there may have been other factors that contributed to this event but they are not known at this time. Due to this being a one-off event where the originator has provided limited information, it is not possible to conclude why the medical professional had difficulty verifying the placement of the device. Per the quality engineering risk assessment, no further action is warranted. Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[120562153]
No new event information has been received since the initial report was submitted on 30may2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01537 |
| MDR Report Key | 7555506 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-30 |
| Date of Report | 2018-08-16 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-05-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRATHANE SUPRAPUBIC CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-05-30 |
| Catalog Number | USCS-140025 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-30 |