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

Model Number CAT6

Device Problem Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

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 femoral and popliteal arteries using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, the physician had difficulty introducing the cat6 into the sheath using the peel-away introducer sheath.Therefore, the cat6 was removed.The procedure was completed using another cat6 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the cat6 was kinked approximately 29.5, 31.0, and 38.0 cm from the hub.The cat6 was stretched approximately 128.5 thru 132.5 cm from the hub.The cat6 was ovalized approximately 132.5 thru 137.0 cm.The total length of the cat6 was 137.0 cm.Conclusions: evaluation of the returned cat6 revealed that the distal shaft of the catheter was ovalized and stretched.If the cat6 is forcefully gripped or pinched during insertion of the catheter into the peel-away sheath, damage such as ovalization may occur.Subsequently, if the cat6 is forcefully retracted against resistance, damage such as stretching may occur.The root cause of resistance could not be determined.During the functional test, resistance was encountered while attempting to advance the cat6 through a demonstration peel-away sheath and a demonstration neuron max, and the cat6 could not be advanced at all.Further evaluation of the returned cat6 revealed kinks and ovalizations.This damage was likely incidental to the reported complaint.Penumbra catheters are visually 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.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: 10618057
• MDR Text Key: 209619984
• Report Number: 3005168196-2020-01625
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F95713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• 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: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR