MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Model Number	5MAXJET7BKIT-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2021
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 m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), benchmark bmx96 access system (benchmark max), and velocity delivery microcatheter (velocity).During the procedure, the physician advanced the velocity and jet7 to the face of the clot, the velocity was then removed and the physician-initiated aspiration using the jet7.After approximately two minutes, the clot was observed to be coming through the jet7.The physician then performed a contrast run resulting in thrombolysis in cerebral infarction (tici) 3.Subsequently, while retracting the jet7, the physician noticed the jet7 became stuck and could not be retracted.The physician continued to pull the jet7 and consequently, the distal end of the jet7 broke off in the m1.It was also reported that prior to removing the jet7, the physician noticed that the jet7 was slightly herniating into the external artery and the jet7 became broken at the junction of the internal and external artery.After approximately an hour and multiple attempts using a snare device, the physician was able to successfully remove the broken distal end of the jet7.The physician ended the procedure at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed that the catheter was stretched and fractured.This damage typically occurs due to forceful retraction against resistance.The complaint reported the catheter was herniating into the eca prior to retraction.This likely contributed to resistance upon retraction causing the catheter to stretch and fracture.Additional damage may have occurred during the snaring process of the fractured catheter segment.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 JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12089794
• Report Number: 3005168196-2021-01440
• Device Sequence Number: 4013903
• Product Code: NRY
• UDI-Device Identifier: 00815948023246
• UDI-Public: 00815948023246
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• 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): 07/23/2021
• 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: 01/08/2024
• Device Model Number: 5MAXJET7BKIT-A
• Device Catalogue Number: 5MAXJET7BKIT
• Device Lot Number: F103182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: 87 YR
• Date Report Sent to FDA: 01/01/2005