MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-07-06 for ARROW CONTINUOUS NERVE BLOCK KIT AB-20608-K manufactured by Arrow International Inc..
[6022984]
The patient had an interscalene catheter placed in the neck by an anesthesiologist prior to shoulder surgery on (b)(6) 2015. The patient was instructed on how to remove the catheter which was to be done on (b)(6) 2015. The patient's friend attempted to remove the catheter and met with resistance and so cut the catheter. The patient experienced discomfort. The patient is to be seen by an ent for intervention in removal of the remaining catheter.
Patient Sequence No: 1, Text Type: D, B5
[14493616]
(b)(4). It is unknown if the device sample is available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[23943265]
(b)(4). No lot number was provided by the customer; therefore, a device history record (dhr) review was performed on a lot number based on customer sales history. Complaint verification testing could not be performed as no sample was returned for analysis. A dhr review was performed on the catheter with no evidence to suggest a manufacturing related cause. The customer reported that the catheter was removed by a friend of the patient and also that the catheter was cut. Both of these details indicate that the catheter was used against the warnings provided in the ifu. Therefore, it was determined that user error caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[23943266]
The patient had an interscalene catheter placed in the neck by an anesthesiologist prior to shoulder surgery on (b)(6) 2015. The patient was instructed on how to remove the catheter which was to be done on (b)(6) 2015. The patient's friend attempted to remove the catheter and met with resistance and so cut the catheter. The patient experienced discomfort. The patient is to be seen by an ent for intervention in removal of the remaining catheter.
Patient Sequence No: 1, Text Type: D, B5
[25347128]
(b)(4). The customer returned one catheter fragment for investigation. A visual exam was performed and the catheter piece appears to be the bulleted tip from the distal end of a stimucath. No extrusion was received. The coils were severely stretched and the safety ribbon could be seen in between the coils. The safety ribbon appears to have been cut at the point of separation as there were signs of necking in the metal that is typical of metal that has been cut. The reported complaint of a difficult removal resulting in catheter separation was confirmed based on the returned sample. The customer returned a catheter fragment only which confirmed that the catheter had been cut. A dhr review was performed on the catheter with no evidence to suggest a manufacturing related cause. The customer reported that the catheter was removed by a friend of the patient and also that the catheter was cut. Both of these details indicate that the catheter was used against the warnings provided in the ifu. Therefore, it was determined that user error caused or contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
[25347129]
The patient had an interscalene catheter placed in the neck by an anesthesiologist prior to shoulder surgery on (b)(6) /2015. The patient was instructed on how to remove the catheter which was to be done on (b)(6) 2015. The patient's friend attempted to remove the catheter and met with resistance and so cut the catheter. The patient experienced discomfort. The patient is to be seen by an ent for intervention in removal of the remaining catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2015-00278 |
| MDR Report Key | 4891641 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-07-06 |
| Date of Report | 2015-06-19 |
| Date of Event | 2015-06-18 |
| Date Mfgr Received | 2015-09-03 |
| Date Added to Maude | 2015-07-06 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW CONTINUOUS NERVE BLOCK KIT |
| Generic Name | NERVE BLOCK KIT |
| Product Code | OGJ |
| Date Received | 2015-07-06 |
| Returned To Mfg | 2015-08-24 |
| Catalog Number | AB-20608-K |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-06 |