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

Catalog Number 5MAXACE068

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, the physician noticed that the ace68 was leaking near the hub during aspiration and the proximal end of the ace68 was found to be broken.Therefore, the ace68 was removed.The procedure was completed using a new ace68.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned ace68 was kinked at approximately 1.0 cm from the hub.During functional testing, the ace68 was flushed through with air while submerged in the bleach solution.The air leaking was observed from the kink.Conclusions: evaluation of the returned ace68 revealed that the catheter was leaking under the strain relief on the proximal end.This kind of damage was likely a result of forcefully manipulating the catheter at extreme angles outside the patient body.This kink likely contributed to the leaking observed during the procedure and functional testing.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: 8144386
• MDR Text Key: 129760138
• Report Number: 3005168196-2018-02390
• 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: 01/01/2005,11/09/2018

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: Health Professional
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F84845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR