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

Catalog Number	5MAXACE132
Medical Device Problem Codes	Fracture (1260); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra system 5max ace reperfusion catheter (5max ace) was stretched and fractured approximately 108.5 cm from the hub.Conclusions: evaluation of the returned device confirmed that the 5max ace was stretched and fractured.It is possible for the 5max ace to become pinned against patient anatomy or other devices used in the procedure.If the 5max ace becomes pinned or otherwise restrained, and is then forcefully retracted, damage such as this may occur.The non-penumbra guiding catheter mentioned in the complaint was not returned for evaluation.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 or Problem Description
The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system 5max ace reperfusion catheter (5max ace).During the procedure, the physician did not mention resistance while advancing a 5max ace in the target vessel using a non-penumbra 16f guiding catheter.The physician then completed two passes with the 5max ace using the adapt technique.After completion of the second pass, the physician decided to pull the 5max ace back into the guide catheter; however, resistance was encountered and the physician pulled the 5max ace back despite the resistance.Upon removal, the physician noticed that the 5max was fractured at the mid-shaft.The procedure was completed after the removal of the 5max ace.Although there was no report of an adverse effect to the patient; however, multiple attempts have been made and confirmation is pending.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter (5max ace).It was noted that the patient was occluded from the vertebral artery to the basilar artery.In addition, it was noted that the patient had a very excessive tortuous vertebral artery.During the procedure, the physician did not mention resistance while advancing a 5max ace in the target vessel using a non-penumbra 16f guiding catheter.The physician then completed two passes with the 5max ace using the adapt technique.After completion of the second pass, the physician decided to pull the 5max ace back into the guide catheter and inflated the non-penumbra balloon catheter; however, resistance was encountered and the physician pulled the 5max ace back despite the resistance.Upon removal, the physician noticed that the 5max was fractured at the mid-shaft.The procedure was completed after the removal of the 5max ace.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6800978
• Report Number: 3005168196-2017-01386
• Device Sequence Number: 18980290
• Product Code: NRY
• UDI-Device Identifier: 00814548012803
• UDI-Public: 00814548012803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

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
• Operator of Device: Physician
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F74440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1