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

Catalog Number 5MAXACE068KIT

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2019

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

During preparation for a medical procedure using a penumbra system ace 68 hi-flow kit, the penumbra system ace 68 reperfusion catheter (ace68) was found to be broken at the proximal end upon removal from the kit packaging.The damage to the ace68 was found prior to use and therefore it was not used in the procedure.The procedure was completed using another ace68 from a new kit.

Event Description

During preparation for a medical procedure using a penumbra system ace 68 reperfusion catheter (ace68) from a penumbra system ace 68 hi-flow kit, and a penumbra system 3max reperfusion catheter, the ace68 was found to be broken at the proximal end upon removal from the kit packaging.The damage to the ace68 was found prior to use and, therefore, it was not used in the procedure.The physician then began using a 3maxc and another ace68 from a new kit to continue the procedure.A report was received on 07-mar-2019 which indicated that after advancement of the ace68 over the 3maxc into the m1 segment of the middle cerebral artery (mca), the physician retracted the 3maxc to remove it and reported that the proximal part of the catheter broke as it was passing through the rotating hemostasis valve (rhv).The 3maxc was then completely removed and the procedure was completed successfully using the same ace68.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the ace68 was fractured approximately 57.5 cm from the hub.Conclusions: evaluation of the returned ace68 confirmed a fracture.If the device is retracted out of its packaging tray without removing the top portion of the tray, the ace68 may become wedged between the two trays and result in a fracture.Evaluation of the returned 3maxc confirmed a fracture.If the device was forcefully retracted through a tightened rhv or at an extreme angle through the rhv, damage such as a fracture may occur.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.

• 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: 8356622
• MDR Text Key: 136743531
• Report Number: 3005168196-2019-00305
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (y/n): Y
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F85406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• 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: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1