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

Catalog Number CAT8XTORQ115

Device Problems Crack (1135); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

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 iliac vein using indigo system aspiration catheters 8 (cat8s).During the procedure, the physician connected a cat8 to a penumbra system aspiration pump max 220v (pump max) and turned on the pump max.However, upon turning the pump max on, the physician noticed that air seemed to come through the proximal end of the cat8; therefore, the cat8 was disconnected from the pump max.Upon disconnecting the cat8, the physician noticed a hairline crack where the aspiration tubing is connected to the cat8.Therefore, the cat8 was removed from the patient and the procedure was completed using a second cat8.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The indigo system aspiration catheter 8 (cat8) hub was cracked.The device was kinked and bent along its length.Evaluation of the returned device cat8 revealed the hub was cracked.The hub leaked when attempting to flush saline through the catheter during functional testing.This damage is likely a result of mishandling or overtightening during use.Further evaluation revealed a kink and bends along the length of the catheter.These damages were likely incidental and 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6828852
• MDR Text Key: 83987052
• Report Number: 3005168196-2017-01450
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

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: 07/14/2019
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F70613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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: 32 YR