MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number 3MAXC

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2015

Event Type  Injury  

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 middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3max).During the procedure, after removing the 3max from the patient, the physician noticed that 10 inches of the distal end was missing and left in the mca.The physician required a penumbra system 4max reperfusion catheter and a snare device to remove the broken 3max from the patient.The procedure was stopped at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: the penumbra system 3max reperfusion catheter (3maxc) was stretched and fractured approximately 124.0 cm from the hub.The coil wind component of the 3maxc was unwound, but still intact.Conclusion: evaluation of the returned device revealed that the 3maxc was stretched and fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, the tensile strength of the catheter may be overcome, and damage such as this may occur.3maxcs are 100% visually inspected for damage during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5396449
• MDR Text Key: 37011734
• Report Number: 3005168196-2016-00099
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012490
• UDI-Public: 00814548012490
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133317
• 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: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 3MAXC
• Device Lot Number: F65174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR