MAUDE Adverse Event Report: SOFT-VU SIZING ANGIOGRAPHIC CATHETER

Catalog Number	10714009
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a sv ber 4fx65cm.038 nb angiographic catheter.During a procedure to place a biliary drain,the doctor reported using the catheter through an accustick and over a 0.035 ampaltz wire.He reported he had to push pretty hard to get the catheter through the tumor to the bowel.On withdrawal, the end got stuck in the end of the accustick, and when force was applied to remove it, the tip broke off.He pulled everything back as a unit and the tip came out with the accustick.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was an angiographic catheter and an unknown "dilator", likely boston scientific accustick device.The review of the returned catheter shows the tip of the catheter is detached.A review of the complaint sample indicated that the soft tip had been broken approximately 1cm distal of the weld.The site of the fracture showed evidence of stretching and tearing.An attempt was made to pass the remaining portion of the catheter through the accustick assembly, which was successfully accomplished but with significant hesitation/resistance at the location of the ro band.The condition of the detached tip was such that it had been "this resistance is the likely source of the difficulty in withdrawal (resulting in excessive force placed upon the catheter to remove it) and its ultimate failure.The remaining portions of the catheter were measured for od and found to be in specification.A review of the incoming inspection data did not indicate any anomalies with the lot of soft-tip material.The material tensile specification of the soft-tip component is 6 lbs.Minimum." the customer's reported complaint description of the tip detached from the catheter was confirmed.A possible root cause for the tip detaching as indicated by engineering evaluation of the returned complaint sample could be due to "hesitation/resistance at the location of the ro band of the returned accustick ".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.Labeling review: 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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• MDR Report Key: 11965762
• Report Number: 1319211-2021-00043
• Device Sequence Number: 17210627
• Product Code: DQO
• UDI-Device Identifier: H787107140095
• UDI-Public: H787107140095
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 10714009
• Device Lot Number: 5645608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1