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

Model Number 5MAXJET7KIT-B

Device Problem Break (1069)

Patient Problem Fistula (1862)

Event Date 07/04/2020

Event Type  Injury  

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 Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), a penumbra system aspiration pump max 110 (pump max), a non-penumbra catheter, a non-penumbra microcatheter, a non-penumbra stent retriever device, and a wire.During the procedure, the physician advanced the jet7, microcatheter and stent retriever device through the neuron max and up to the thrombus.The physician then deployed the stent retriever device, removed the microcatheter and turned on the pump max for aspiration.Subsequently, the stent retriever with the clot was pulled back into the jet7 and removed.With the jet7 in the carotid terminus, the physician did a contrast injection and noticed a carotid-cavernous sinus fistula (ccf).Next, while advancing a wire through the jet7, the wire went out the side of the jet7, and the physician realized that the distal tip of the jet7 was broken and was in the carotid.Therefore, the physician snared out the tip of the jet7 and coiled the ccf.The procedure ended at this point.The ccf was reported to be related to the jet7.The patient is currently recovering from the severe stroke suffered prior to the procedure.

Manufacturer Narrative

Potential adverse events with the penumbra system include arteriovenous fistula, false aneurysm formation, acute occlusion, device malfunction, emboli, hematoma or hemorrhage at the site, inability to completely remove thrombus, ischemia, dissection or perforation and death are included in the labeling.Therefore, it was determined that the reported carotid cavernous fistula (ccf) was an anticipated procedural complication.Results: the jet7 was kinked approximately 21.5 cm from the hub.The jet7 was ovalized approximately 112.0 thru 117.0 cm from the hub.The jet7 was fractured approximately 129.5 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed the fracture on the distal shaft.Catheter fracture typically occurs due to retraction against resistance.It is possible the catheter became damage during the first pass performed with solitaire.If an angiogram is performed through a damaged catheter, additional catheter damage may result.Further evaluation of the returned jet7 revealed ovalization and kinks.This damage was likely incidental to the reported complaint.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.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10348254
• MDR Text Key: 201233578
• Report Number: 3005168196-2020-01064
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020962
• UDI-Public: 00815948020962
• Combination Product (y/n): Y
• PMA/PMN Number: K190010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F94645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR