MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Catalog Number CAT6

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the popliteal artery using an indigo system aspiration catheter 6 (cat6).It was reported that the patient¿s anatomy was narrow.During the procedure, while advancing the cat6 with the peel away sheath and through an introducer using the crossover technique, the physician experienced resistance, and subsequently, noticed that the distal tip of the cat6 was bent under fluoroscopy; therefore, the cat6 was removed.The procedure was completed with balloon angioplasty.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned cat6 was ovalized at its distal shaft approximately 127.0 cm and 132.0 cm - 135.0 cm from the hub.The device had multiple kinks at approximately 130.0 cm and 131.0 cm from the hub.During functional testing, the returned cat6 was unable to be advanced into a demonstration neuron max due to the distal ovalization.Conclusions: evaluation of the returned cat6 revealed kinks and ovalizations along the catheter distal shift.If the device is forcefully advanced against resistance, damages such as these may occur.The non-penumbra introducer used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9251995
• MDR Text Key: 164248451
• Report Number: 3005168196-2019-01999
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2021
• Device Catalogue Number: CAT6
• Device Lot Number: F84232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR