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

Catalog Number	5MAXACE064
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2016
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.This report is associated with mfr report numbers: 1.3005168196-2016-00109, 2.3005168196-2016-00111.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the carotid artery using a neuron max 6f 088 long sheath (neuron max), a penumbra system ace 64 reperfusion catheter (ace 64) and a penumbra system 3max reperfusion catheter (3max).During the procedure, while the neuron max was being advanced in the patient, it became kinked.The physician did not report any resistance and did not apply any force; however, it was indicated that there was tortuous arch access.Due to the neuron max being kinked, the ace 64 and the 3max catheter were both stretched while being retracted through the kinked area of the neuron max.All three devices were removed and the procedure was completed using a new neuron max, a new ace 64 and a new 3max catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the penumbra system ace 64 reperfusion catheter (ace 64) was kinked approximately 81.0 cm from the hub and stretched from approximately 108.0 cm from the hub to the distal tip.Conclusions: evaluation of the returned devices revealed the neuron max was kinked.This damage may have occurred due to forceful manipulation of the neuron max during advancement.The tortuous anatomy mentioned in the complaint may have also contributed to the damage on the neuron max.Further evaluation revealed the ace 64 was stretched and kinked.This damage likely occurred due to forceful retraction of the ace 64 through the damaged neuron max.The 3max mentioned in the complaint was not returned for evaluation.All penumbra catheters are visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 5404033
• Report Number: 3005168196-2016-00110
• Device Sequence Number: 16238918
• Product Code: NRY
• UDI-Device Identifier: 00814548013961
• UDI-Public: 00814548013961
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 01/05/2016

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: 06/08/2018
• Device Catalogue Number: 5MAXACE064
• Device Lot Number: F64315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2016
• Supplement Report FDA Received Date: 05/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR