MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER D

Catalog Number CATD

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

The indigo system aspiration catheter d (catd) was fractured approximately 0.8 cm from the hub.Evaluation of the returned device revealed that the catd was fractured.This type of damage likely occurred from forceful handling of the catd hub during use.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 in the iliofemoral artery using an indigo system aspiration catheter d (catd).During the procedure, after about forty-five minutes of use, the physician inadvertently twisted off the proximal end of the catd.The physician indicated that he twisted the catd the wrong way.Therefore, the catd was removed and the procedure was completed using an indigo system aspiration catheter 8 (cat8).There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: 1.Box 5.510(k).Additional 510(k) #s that also apply to this complaint: k160533.K161523.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER D
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6505449
• MDR Text Key: 73253549
• Report Number: 3005168196-2017-00619
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (y/n): Y
• PMA/PMN Number: K142870
• 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: 01/01/2005,03/22/2017

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: 02/14/2020
• Device Catalogue Number: CATD
• Device Lot Number: F74426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• 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: 03/22/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR