MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Catalog Number 5MAXACE132

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system 5max ace reperfusion catheter (5max ace) was kinked approximately 43.0 and 46.0 cm from the hub.The outer diameter (od) of the 5max ace was measured and found to be within specification.The 5max ace was dipped in water and checked for coating lubricity.Lubricity was present along the catheter shaft.Conclusions: evaluation of the returned device revealed that lubricity was present on the 5max ace during the functional analysis.The od of the 5max ace was measured and found to be within specification.The non-penumbra sheath mentioned in the complaint was not returned for evaluation.Therefore, the root cause of this complaint cannot be determined.The kinks in the 5max ace likely occurred during the attempt to introduce the 5max ace against resistance through the non-penumbra sheath.The 5max ace's 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.

Event Description

The patient was undergoing a thrombectomy procedure in the popliteal artery using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the physician was unable to introduce the 5max ace more than halfway into another manufacturer's sheath.The physician removed the 5max ace and completed the procedure using a new 5max ace and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE 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: 5236973
• MDR Text Key: 31631669
• Report Number: 3005168196-2015-01168
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• 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: Other
• Type of Report: Initial
• Report Date: 10/21/2015

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: 01/31/2018
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F62198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2015
• 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 Age: 30 YR