MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE064-A
Medical Device Problem Codes	Air Leak (1008); Physical Property Issue (3008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2016
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 using a penumbra system ace 64 reperfusion catheter (ace 64).During the middle of procedure, the technologist heard air and then noticed that there was a leak at the hub of the ace 64.The ace 64 was removed from the patient and the procedure was completed using a new ace 64.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: upon first evaluation of the returned penumbra system ace 64 reperfusion catheter (ace 64), the strain relief was offset.The strain relief was partially unwound by a penumbra investigator to reveal the ace 64 was fractured under the strain relief approximately 1.0 cm from the hub.Conclusion: evaluation of the returned device revealed it was fractured under the strain relief.This type of damage typically occurs due to forceful manipulation at extreme angles during preparation or use.The fracture under the strain relief likely caused the leaking that was reported in the complaint.Penumbra catheters are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
510(k): k142458.

• Brand Name: PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5411661
• Report Number: 3005168196-2016-00121
• Device Sequence Number: 620859
• Product Code: NRY
• UDI-Device Identifier: 00814548016207
• UDI-Public: 00814548016207
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date (Section B): 01/06/2016

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: Physician
• Device Expiration Date: 08/25/2018
• Device Catalogue Number: 5MAXACE064-A
• Device Lot Number: F65468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/04/2016
• Supplement Report FDA Received Date: 06/22/2016; 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR