MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-02-17 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER N/A J-CHSG-703001 manufactured by Cook Inc.
[67722060]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[67722061]
It was reported by the sales rep that a patient underwent a procedure to manage decompression. The two attending physicians decided to use the harrison fetal bladder stent set for a fetal chest (lung for pleural effusion) procedure which is contraindicated and against instructions for use. The sales rep, was unable to advise them nor was able to comment on the failure of the device in this capacity and stressed this was not indicated for that use. The procedure was unsuccessful, the product positioner was bent during surgery and the patient has to return the following week for another operation. There were no unintended sections of the device that remained inside of the patients? Body, nor did the patient experience any adverse effects due to this occurrence. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[74379318]
Investigation - evaluation: a review of complain history, device history record, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation. The complaint device was not returned for investigation. There is no indication that a design or process related failure mode contributed to this event. Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. Based on the provided information, no conclusion can be drawn hence the root cause is unknown. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required. Per the risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[74528785]
Investigation - evaluation: a review of the instruction for use (ifu), quality control and specification of the device was conducted during the investigation. The complaint device was not returned for investigation. There is no indication that a design or process related failure mode contributed to this event. Review of the ifu and quality documentation did not observe any specific issues with current controls that may have contributed to this incident. Review of device history and complaint history could not be conducted since the lot number was not provided. The harrison fetal bladder stent set (hfbs) is designed and intended for use in a fetal bladder organ with the condition indicated. However, the customer used the product in a fetal chest (lung for pleural effusion) which is contraindicated and against the ifu. Based on the provided information the root cause is product use or handling related because the surgeon did not follow instructions for use of the device. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required. Per the risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-00203 |
| MDR Report Key | 6340656 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-02-17 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2016-11-29 |
| Date Added to Maude | 2017-02-17 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER |
| Generic Name | MPR STENT, BLADDER, FETAL |
| Product Code | MPR |
| Date Received | 2017-02-17 |
| Model Number | N/A |
| Catalog Number | J-CHSG-703001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2017-02-17 |