MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 3 ASPIRATION CATHETER; DXE

Catalog Number CAT3

Device Problem Material Fragmentation (1261)

Patient Problem Reocclusion (1985)

Event Date 11/16/2018

Event Type  Injury  

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 underwent a thrombectomy procedure in the tibial vessel on (b)(6) 2018 using an indigo system cat3 aspiration catheter (cat3).While removing the cat3 from the non-penumbra sheath, the cat3 began to deform and stretch.However, the physician thought the entire cat3 had been removed.The physician then performed a fluoroscopy and confirmed the vessel was clear of thrombus, so the procedure ended after the cat3 had been removed.On (b)(6) 2018 or (b)(6) 2018, the patient underwent a computerized tomography (ct) scan and it was confirmed that the vessels were still patent and no retained foreign body was reported.However, the patient presented with leg pain and was readmitted with re-occlusion of the left popliteal artery on (b)(6) 2018.An initial ultrasound scan of the left popliteal artery revealed occlusion with a linear "tube like" structure within it.A ct was also performed showing a retained foreign body within the left popliteal artery.The physician then found that 15 cm of the cat3 had broken off during the initial procedure in the patient¿s popliteal artery, causing the vessel to reocclude.The physician therefore performed another procedure and used a snare device to remove the piece of the cat3 and administered thrombolysis.It was reported that the vessel is now flowing to the patient¿s ankle.As of (b)(6) 2019, the patient has been discharged and reported that his leg ¿was feeling much better¿.

Manufacturer Narrative

Results: the cat3 was fractured and the proximal portion of the fractured catheter was not returned for evaluation.The returned portion of the catheter was stretched, kinked, and ovalized.Conclusions: evaluation of the returned cat3 confirmed that the device was fractured.The proximal fractured portion of the cat3 was not returned.Based on site of the stretch damage, the device likely became pinned within patient anatomy.This may have contributed to resistance upon retraction.If the cat3 is forcefully retracted against resistance, the device may stretch and fracture.Additional damage likely occurred due to the snare used in the removal procedure.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.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report:3005168196-2019-00042.

• Brand Name: INDIGO SYSTEM CAT 3 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8234332
• MDR Text Key: 132639867
• Report Number: 3005168196-2019-00042
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• 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,Followup
• Report Date: 01/01/2005,12/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2021
• Device Catalogue Number: CAT3
• Device Lot Number: F82825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• 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: 12/11/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 01/14/2005
• Supplement Dates FDA Received: 03/29/2019; 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR