MAUDE Adverse Event Report: ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number	13709803
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer for a device evaluation.The results of the device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Complaint # (b)(4).
Event or Problem Description
As reported (b)(6) 2016, a (b)(6), male patient presented for an angiographic procedure.During the case, after the angiographic catheter had been placed, the strain relief detached and slid down the catheter shaft and into the insertion site.The strain relief was removed with no complications or patient effect.The catheter was removed and set aside.A new of the same was used to successfully complete the procedure.There was no harm or injury to the patient due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a accu-vu catheter.The hub was not received for evaluation.A visual review of the catheter noted that the hub was missing and the strain relief falls loosely along the shaft of the device.The material at the end of the shaft, where the hub is attached, appears stretched.The customer's reported complaint description of the strain relief detaching is confirmed.A definitive root cause for the reported complaint description cannot be determined, although it does not appear to be manufacturing related.During the sample analysis, the portion of the shaft where the strain relief is molded to the hub processes damage that could have been caused by excessive force or torque.Though it cannot be definitely determined, the most likely cause to this complaint is due to handling techniques during the procedure.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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.Complaint # (b)(4).

• Brand Name: ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5662540
• Report Number: 1319211-2016-00080
• Device Sequence Number: 16155732
• Product Code: DQO
• UDI-Device Identifier: H787137098035
• UDI-Public: H787137098035
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K032376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 13709803
• Device Lot Number: 4921673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• 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
• Patient Age: 73 YR