MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER`; DXE

Catalog Number CAT5-A

Device Problems Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 using an indigo system cat5 aspiration catheter (cat5).During the procedure, while attempting to advance the cat5 through a non-penumbra sheath, the physician experienced resistance and was unable to advance the cat5; therefore, it was removed.Upon removing the cat5, the physician noticed it was too big for the sheath and it became flattened and stretched.The procedure was successfully completed using an indigo system cat 3 aspiration catheter and a larger non-penumbra sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The indigo system aspiration catheter (cat5) was bent in two locations along the shaft.The cat5 was kinked and ovalized in multiple locations from approximately 110 cm from the hub to the distal tip of the catheter.Evaluation of the returned device confirmed that the cat5 was ovalized.If an attempt is made to advance a cat5 through an incorrectly sized sheath, resistance will be experienced.Furthermore, if the cat5 is forcefully gripped or otherwise pinched during insertion into the patient anatomy, the catheter may become ovalized.The observed ovalizations likely further contributed to the resistance mentioned in the initial complaint.Further evaluation revealed multiple kinks and bends along the catheter shaft.This damage likely occurred due to forceful advancement against resistance.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 CAT5 ASPIRATION CATHETER`
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5895199
• MDR Text Key: 52732191
• Report Number: 3005168196-2016-01211
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/11/2019
• Device Catalogue Number: CAT5-A
• Device Lot Number: F68405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• 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