MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETER

Catalog Number	H787107140335
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205); Device Issue (2379)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported december 07, 2016, a (b)(6), female patient presented for an medical procedure.During the procedure, standard atraumatic steel wire was used with the hockey stick for access in a biliary drainage case.As the guide wire was threaded using normal, atraumatic procedure, instead of straightening the catheter tip, the guide wire perforated the catheter side wall.No adverse outcome for patient, procedure carried on to conclusion.The guide wire product used - cook rosen curved guide wire - standard for the procedure.Catheter removed intact.There was no harm or injury to the patient due to this event.The reported defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a 4f soft-vu catheter.The tip straightener was removed and was not returned.A visual of the catheter noted a hole in the soft tip.A guidewire from stock was advanced through the catheter.The wire protrudes from the site of the perforation in the soft tip.The customer's reported complaint description of a perforation in the tip of the catheter is confirmed.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, manufacturing verifies that a.038" guidewire is able pass freely though the catheter.As tip straightener was not returned with the device, it is possible that the user attempted to hand straighten the tip while advancing it over the wire, inevitably, puncturing the wall of the soft tip.This is contradictory to the ifu.Though this theory cannot be definitively determined, a possible root cause could be due to the user technique.The patient was unaffected due to this event.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: SOFT-VU ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6178520
• Report Number: 1319211-2016-00166
• Device Sequence Number: 13669564
• Product Code: DQO
• UDI-Device Identifier: H787107140335
• UDI-Public: H787107140335
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: H787107140335
• Device Lot Number: 5074713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 03/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR