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

Catalog Number	10723502
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A distributor reported an issue with a sv beren 4fx65cm.035 b angiographic catheter.During an angiogram procedure, the catheter tip broke off while the device was being withdrawn from the patient.The tip fragment was removed via snare and the procedure was completed.The patient did not experience any adverse effects or harm as a result of this issue.
Additional Manufacturer Narrative
Returned for evaluation was an angiographic catheter.The returned catheter's tip was detached.The tip shows stretching at the catheter shaft end.Manufacturing engineer evaluation: a review of the complaint sample indicated that the soft tip had broken approximately 3cm distal of the weld.The condition of the deformation of the detached soft tip was not focused upon as components can become damaged by the use of the snare, but the condition of the tip that remained attached indicates significant force was placed on it during withdrawal, leading to its ultimate failure.The material was not found to have become embrittled and remained soft and pliable.The catheter and undeformed portions of the soft tip readily accommodated a 0.035" guidewire without issue.The original complaint description did not mention any difficulty in withdrawal, but the tip is visibly stretched and torn as opposed to exhibiting a clean break.The cause of this difficulty cannot be ascertained.The customer's reported complaint description of the tip detached from the catheter was confirmed.The root cause of the tip detachment cannot be definitively determined but likely root cause is excessive tensile force applied during catheter withdrawl, i.E.Handling damage.This is evidenced by the stretched nature of the failure location a review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.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
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13977453
• Report Number: 1319211-2022-00015
• Device Sequence Number: 6032127
• Product Code: DQO
• UDI-Device Identifier: H787107235025
• UDI-Public: H787107235025
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: 09/30/2024
• Device Catalogue Number: 10723502
• Device Lot Number: 5703106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Patient Age: 83 YR
• Patient Sex: Female