MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064-A
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Retraction Problem (1536)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	03/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) using a penumbra system ace 64 reperfusion catheter (ace 64).During the procedure, a neuron max 6f 088 long sheath (neuron max) was inserted into the left ica and then the ace 64 was advanced to the proximal side of the m1 occlusion over a velocity delivery microcatheter (velocity) and guidewire.The velocity and guidewire were removed and aspiration was initiated using the penumbra system aspiration pump max 110v (pump max).The m1 clot was removed utilizing the adapt technique.While withdrawing the ace 64 from the neuron max, the physician experienced resistance and therefore, applied additional pulling force in order to withdraw the ace 64.An angiogram was then performed, which confirmed that the clot had been successfully removed from the m1; however, it also revealed that an approximate 25 centimeter segment of the ace 64 distal tip was left in the patient's ica.The broken segment of the ace 64 extended from the ophthalmic portion of the ica down into the external carotid artery.The ace 64 segment was not occlusive to the ica and adequate blood flow around the ace 64 was observed.Several unsuccessful attempts were made to snare the ace 64 segment; ultimately, the patient was sent to surgery, and the entire 25 centimeter distal piece of the ace 64 was successfully removed through a carotid incision.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) started to stretch approximately 103.5 cm and fractured approximately 122.5 cm from the hub.Conclusions: evaluation of the returned device confirmed that the ace64 was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.The neuron max and the velocity mentioned in the complaint were not returned to penumbra for evaluation.Ace64 catheters are 100% visually inspected 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 ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5544982
• Report Number: 3005168196-2016-00424
• Device Sequence Number: 963379
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/03/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F65586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Supplement Report FDA Received Date: 05/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR