MAUDE Adverse Event Report: PERFORMA®.NON-BRAIDED.DIAGNOSTIC CATHETER; PERIPHERAL CATHETERS

Catalog Number	510035AVS20MHK
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous interventional peripheral vascular procedure, the catheter shaft detached.The physician had acquired right contralateral retrograde femoral artery access and successfully place a 6f introducer sheath.The physician had successfully negotiated the patient's common iliac bifurcation under fluoroscopy with a guidewire and the 5f catheter.During catheter manipulations within the patient's left superior femoral artery [sfa] the catheter shaft detached [mid shaft].Secondary access was successfully acquired, and an additional diagnostic catheter was introduced again under fluoroscopy.During an attempt to retrieve the first detached catheter [foreign body], the second catheter detached as well [mid shaft] and was successfully removed from the patient while still on the guidewire.The access sheath was upsized to 8f to accommodate the successful retrieval of the primary foreign body [catheter] via vascular snare device.The physician then proceeded to successfully finish the vascular intervention without any additional consequences to report.The patient tolerated the procedure well.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERFORMA®.NON-BRAIDED.DIAGNOSTIC CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• MDR Report Key: 11135878
• Report Number: 3010665433-2021-00001
• Device Sequence Number: 4006241
• Product Code: DQO
• UDI-Device Identifier: 00884450028940
• UDI-Public: 884450028940
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: Health Professional
• Device Expiration Date: 09/16/2023
• Device Catalogue Number: 510035AVS20MHK
• Device Lot Number: E1938760
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR