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

Model Number 5MAXACE068

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and a penumbra system aspiration pump max 220 (pump max).During the procedure, while the pump max was powered on, the physician felt some shaking when the distal end of the ace68 moved on the monitor and subsequently, the physician decided to remove the ace68.Upon removal of the ace68, it was noticed that the distal end of the ace68 was stretched.Therefore, the ace68 was not used for the remainder of the procedure.The procedure was completed using a new ace68 and the same pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned ace68 was kinked at approximately 128.0 cm, 129.0 cm, and 132.0 cm from the hub.The total length was measured approximately 133.0 cm from the hub.Conclusions: evaluation of the returned ace68 revealed kinks on its distal shaft.If the device is advanced against resistance, damage such as distal kinks may occur.During functional testing, water was aspirated through the ace68 and the reported shaking on the distal end was not observed.The total length of the ace68 was measured within specification; therefore, the reported distal end stretching could not be confirmed.Penumbra catheters are 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.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10346043
• MDR Text Key: 201233153
• Report Number: 3005168196-2020-01052
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F90059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR