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

Model Number 5MAXJET7KIT

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Results: the jet7 was kinked approximately 3.5 and 80.0 cm from the hub.The marker band was damaged at the distal tip of the jet7.The entire length of the returned jet7 was intact.Conclusions: evaluation of the returned jet7 was unable to confirm the reported distal fracture.The entire length of the returned jet7 was intact.Further evaluation revealed the distal markerband was damaged.This damage may have been due to handling during use.Additionally, there were kinks on the proximal and mid-shaft of the device.This damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a non-penumbra microcatheter, a neuron max 6f 088 long sheath (neuron max), a guidewire and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, the physician advanced the jet7 and microcatheter over the guidewire through the neuron max and into the target vessel to aspirate the clot with no reported resistance.During aspiration while retracting the jet7, the catheter fractured distally.Therefore, the physician removed the jet7 and the fractured tip remained in the patient.Upon removal, it was noticed that the proximal end of the jet7 was kinked.The procedure was completed using an ace68, the same neuron max and microcatheter.However, the fractured distal tip of the jet7 was displaced into the anterior cerebral artery (aca) and was left in the patient¿s body as it was too distal to be retrieved.There was no report of an adverse effect to the patient.After the procedure, the jet7 fractured at the mid-shaft of while it was being packed into the box.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10765488
• MDR Text Key: 214143647
• Report Number: 3005168196-2020-01856
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F94590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR