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

Catalog Number CAT6

Device Problems Collapse (1099); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician encountered resistance while advancing the cat6 into a non-penumbra sheath using a peel away introducer sheath.However, the physician decided to continue advancing the cat6 into the sheath.After advancing the cat6 approximately 3 inches into the sheath, it was reported that the cat6 became crushed and mangled at the distal end.The cat6 was therefore removed and was no longer used in the procedure.The physician decided to use a second cat6 to complete the procedure, but it was reported that the attempt was unsuccessful due to patient anatomy and other vascular issues.The procedure was then discontinued.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the distal tip of the cat6 was ovalized and had multiple consecutive kinks.Conclusions: evaluation of the returned cat6 revealed that the distal tip was ovalized and had multiple consecutive kinks.If the device is forcefully advance against resistance, damage such as an ovalization may occur.In addition, the complaint reported the distal tip of the cat6 was protected by its peel-away introducer sheath.The forceful advancement against resistance likely contributed to the cat6 becoming ovalized.The non-penumbra sheath was not returned for evaluation; therefore, the root cause of initial resistance could not be determined.Penumbra catheters are visually inspected during in-process 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.H3 other text : placeholder.

• 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: 8672680
• MDR Text Key: 147196400
• Report Number: 3005168196-2019-01108
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: CAT6
• Device Lot Number: F88111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR