MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number CAT8XTORQ115

Device Problem Collapse (1099)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

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.This report is associated with mfr report number: 3005168196-2019-00738.

Event Description

The patient was undergoing a thrombectomy procedure in the femoral vein using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).During the procedure, the physician made multiple successful passes using the cat8 with the sep8 and a non-penumbra sheath.The physician then noticed under fluoroscopy that the distal tip of the cat8 was collapsing; therefore the cat8 was removed and was no longer used in the procedure.Additionally, it was reported that while the physician was advancing the sep8, resistance was met after the cat8 collapsed and became ovalized.The procedure was completed using another cat8 the same sep8 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the indigo system aspiration catheter 8 (cat8) was ovalized approximately 10.0 cm, 19.0 cm, 51.5 cm, 58.0 cm, 93.0 ¿ 95.0 cm, 97.0 cm and from 113.0 ¿ 115.5 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed an ovalization at the distal tip.It was reported that the device made approximately five passes into the target vessel prior to the ovalization being discovered.If the cat8 is advanced and retracted multiple times within the patient¿s anatomy, the device may fatigue.This may have contributed to the device becoming ovalized.If the cat8 is ovalized, resistance may be encountered while advancing a separator within the cat8 and also while manipulating the cat8 within the patient¿s anatomy.During functional testing, a demonstration sep8 was advanced in the returned cat8 and resistance was encountered at the distal ovalization.The sep8 was unable to advance further.The root cause of the ovalization could not be determined.Further evaluation revealed additional ovalizations along the length of the cat8.Some of these damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8525054
• MDR Text Key: 142400939
• Report Number: 3005168196-2019-00737
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• 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: 01/01/2005,03/18/2019

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: 12/25/2021
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F87646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• 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: 03/18/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR