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

Catalog Number	3MAXC-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
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 medical procedure in the middle cerebral artery using a penumbra system 3max reperfusion catheter (3maxc).During the procedure, the physician placed a neuron max 6f 088 long sheath (neuron max), a penumbra system jetd reperfusion catheter (jet d), and a 3maxc in the target vessel.The physician then experienced resistance upon removal of the 3maxc.As the physician got to the carotid terminus, upon pulling the 3maxc the distal portion came loose and remained in the patient's body.The physician removed the rest of the 3maxc while the jetd remained in the target location.The physician was able to successfully remove the remaining piece of the 3maxc from the patient's body.The physician felt that the issue was caused by difficult anatomy.The procedure was completed using a new 3maxc, the same neuron max and jet d.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was fractured approximately 148.5 cm from the hub.The fractured distal segment was approximately 16.0 cm and the marker band was present.The total length of the 3maxc with the fractured segment is approximately 164.5 cm.Conclusions: evaluation of the returned 3maxc revealed that the catheter was fractured and stretched.The complaint mentioned that the difficult patient anatomy may have contributed to the resistance experienced during the procedure.If the device is forcefully retracted against resistance, damage such as a fracture and stretching may occur.The neuron max and jetd identified in the complaint was not returned for evaluation.Therefore, the root cause of the reported damage could not be determined.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM MAX 3 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8808561
• Report Number: 3005168196-2019-01408
• Device Sequence Number: 320319
• Product Code: NRY
• UDI-Device Identifier: 00814548019932
• UDI-Public: 00814548019932
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/20/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2022
• Device Catalogue Number: 3MAXC-A
• Device Lot Number: F88817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 45
• Date Report Sent to FDA: 01/01/2005