MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 HI-FLOW KIT; NRY

Model Number 5MAXACE132KIT-A

Device Problems Material Frayed (1262); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the ace60 was stretched from approximately 107.0 cm from the hub to the distal tip.Significant dried blood occluded the lumen of the stretched region of the ace60 catheter shaft.The effective length of the ace60 was measured to be approximately 144.0 cm.No ballooning of the catheter shaft was observed.Conclusions: evaluation of the returned device revealed the ace60 was stretched.It is possible for the ace60 to become pinned against patient anatomy or other devices used in the procedure.If the ace60 becomes pinned or otherwise restrained, and is subsequently forcefully retracted, stretching damage may occur.During functional testing, the ace60 could not be successfully flushed due to significant dried blood occluding the stretched region of the catheter shaft.No ballooning of the catheter shaft was observed during initial evaluation or during attempts to flush the catheter shaft.The neuron max mentioned in the complaint was not returned for evaluation.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.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 hi-flow kit (ace60).During the procedure, on the third pass using the ace60 within a neuron max, the physician removed and flushed the ace60, however as the physician was flushing the ace60 outside of the patient, a balloon formed in the shaft of the ace60.The procedure was therefore completed using the same neuron max and a new catheter.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system ace 60 hi-flow kit (ace60).It was reported that the patient's anatomy was tortuous.During the procedure, on the third pass using the ace60 within a neuron max, the ace60 became damaged.The procedure was completed using the same neuron max and a new catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

(b)(4).

• Brand Name: PENUMBRA SYSTEM ACE 60 HI-FLOW KIT
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7161303
• MDR Text Key: 96712281
• Report Number: 3005168196-2018-00007
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (y/n): Y
• PMA/PMN Number: K160449
• 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: 01/01/2005,12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/13/2020
• Device Model Number: 5MAXACE132KIT-A
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F78158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1