MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Model Number	5MAXACE068KIT
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
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 middle cerebral artery using a penumbra system ace 68 reperfusion catheter (ace68) and a velocity delivery microcatheter (velocity).During the procedure, the physician completed one pass using the ace68 and velocity.During the second pass, the physician advanced the ace68 over the velocity.Next, the physician performed an angiography and noticed a change in the shape of the ace68.Therefore, the ace68 was removed.Upon removal, the physician noticed that the ace68 was stretched at the distal end.Therefore, the ace68 was not used for the remainder of the procedure.The procedure was completed using the same velocity and new ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace68 confirmed that the catheter was stretched.If the catheter is forcefully manipulated against resistance during use, damage such as stretching may occur.The root cause of resistance could not be determined.Further evaluation revealed the ace68 was ovalized.This damage was incidental to the reported complaint, and the root cause could not be determined.During the functional test, resistance was encountered while attempting to advance a demonstration velocity through the returned ace68 due to the stretch in the catheter shaft, and the velocity could not be advanced any further.Resistance was also encountered while attempting to advance the returned ace68 through a demonstration neuron max due to the distal ovalization on ace68, and the ace68 could not be advanced any further.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12211381
• Report Number: 3005168196-2021-01632
• Device Sequence Number: 3181361
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K161640
• 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): 07/22/2021
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F100743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005