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

Catalog Number CAT6

Device Problems Stretched (1601); Physical Resistance (2578); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the indigo system aspiration catheter 6 (cat6) was stretched approximately 127.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the cat6 was stretch.This type of damage typically occurs due to improper handling during use.If the device is advanced without using the peelable sheath, damage to the distal tip of the catheter may occur.Then, if the damaged device is continued to be advanced, it is likely that resistance may be encountered.Additionally, while retracting the damaged device, it is likely that resistance may be encountered.The damaged distal tip of the cat6 likely contributed to the resistance encountered during advancement and during retraction.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.

Event Description

The patient was undergoing a thrombectomy procedure to treat an arterial graft using an indigo system aspiration catheter 6 (cat6).During the procedure, the physician advanced the cat6 through a non-penumbra 6f sheath without using the peelable introducer sheath and reported that it felt snug, but continued to advance the cat6 over the guidewire.The physician then encountered resistance and attempted to retract the cat6 in order to up-size the sheath.While retracting the cat6 from the sheath, the physician met resistance and inadvertently stretched the cat6.Therefore, the procedure was successfully completed using a new cat6 and a non-penumbra 8f sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Pma/510(k) # was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6795814
• MDR Text Key: 82771352
• Report Number: 3005168196-2017-01382
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

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: Physician
• Device Expiration Date: 03/21/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F75125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR