MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Codes	Break (1069); Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the carotid artery using a penumbra system 3max reperfusion catheter (3maxc).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician completed the first pass using the 3maxc, a penumbra system ace 68 reperfusion catheter (ace68), and neuron max 6f 088 long sheath (neuron max).While removing the 3maxc after completion of the pass, the physician experienced around a tight turn and the distal tip of the 3maxc broke off.Therefore, the physician used a snare device to successfully remove the broken tip.The procedure was completed using a new 3maxc and the same ace68 and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were missed or incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report:3005168196-2019-01558.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the carotid artery using a penumbra system 3max reperfusion catheter (3maxc).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician completed the first pass using the 3maxc, a penumbra system ace 68 reperfusion catheter (ace68), and neuron max 6f 088 long sheath (neuron max).While removing the 3maxc after completion of the pass, the physician experienced resistance around a tight turn and the distal tip of the 3maxc broke off.Therefore, the physician used a snare device to successfully remove the broken tip.The procedure was completed using a new 3maxc and the same ace68 and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was kinked approximately 5.0 cm from the hub.The device was fractured approximately 149.0 cm from the hub.The device was stretched and ovalized from approximately 149.0 ¿ 159.0 cm from the hub.The device was ovalized from approximately 161.5 ¿ 162.0 and 165.5 cm from the hub.The total length of the 3maxc was approximately 165.5 cm.Conclusions: evaluation of the returned 3maxc confirmed a fracture and revealed stretching and ovalizations.If the device is forcefully retracted against resistance, damage such as these may occur.Based on the complaint report, tortuous anatomy likely contributed to the resistance experienced during the procedure.Further evaluation revealed additional ovalizations and a kink.This damage was also likely a result of retraction the device against resistance within tortuous anatomy.The ace68 and neuron max identified in the complaint were 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.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8879882
• Report Number: 3005168196-2019-01558
• Device Sequence Number: 16656087
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2019
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2022
• Device Catalogue Number: 3MAXC
• Device Lot Number: F88699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 01/14/2005
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/27/2019; 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005