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

Catalog Number	H787107235035
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/22/2017
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.Complaint # (b)(4).
Event or Problem Description
As reported to angiodynamics on august 23, 2017: during an angiographic procedure, during high pressure injunction of dye, the tip of the catheter detached inside of the patient.The detached fragment was retrieved.The defective device was set aside and a new of the same was used to complete the procedure.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a soft-vu catheter.A visual review of the returned device noted that the shaft is twisted 20cm from the tip.The strain relief/hub is fractured and separated from the shaft.At the site of the fracture, the shaft appears twisted.The customer's reported complaint description of the proximal end separating from the distal is confirmed.A review of the lot history records was performed for the reported packaging for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The returned device possesses evidence of torquing at the site if the fracture.The strain relief remained attached to the hub indicating an adequate internal flair.The most likely root cause for the reported complaint is handling damaged by the user.It was noted that the fractured piece was successfully removed from the patient with no harm or injury.The instructions for use, which is supplied to the end user with this catalog number, contains a statement; "the maximum pressure limit of catheters intended for flush angiography is stated on the catheter package.When using a pressure injector, do not exceed the stated maximum pressure." the ifu also states; "do not attempt to hand straighten the tip of any curved tipped catheters which are furnished with a tip straightener.This may result in damage to the product.Tip straighteners are furnished on all catheters intended to be straightened with the aid of a tip straightener.Reshaping of the catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6833580
• Report Number: 1319211-2017-00085
• Device Sequence Number: 16544142
• Product Code: DQO
• UDI-Device Identifier: H787107235035
• UDI-Public: H787107235035
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 04/30/2020
• Device Catalogue Number: H787107235035
• Device Lot Number: 5186830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/17/2017
• 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