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 06/08/2020

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 right m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), and non-penumbra microcatheter.During the procedure, the physician completed one pass in the target vessel using the jet7 and neuron max.While advancing the jet7 through the neuron max during the second pass, the physician injected contrast media, which revealed the distal tip of the jet7 was fractured.Therefore, the jet7 was removed.After removal of the jet7, it was noticed that the patient had a carotid cavernous fistula.The physician then placed a penumbra smart coil (smart coil) and non-penumbra stent to treat the carotid cavernous fistula.The carotid cavernous fistula was reported to be related to the jet7.

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 stretched from approximately 129.0 ¿ 130.0 cm from the hub.A hole was observed within the stretched region.The total length was approximately 133.0 cm.Conclusions: evaluation of the returned jet7 was unable to confirm the reported fracture, however, stretching was revealed on the distal portion of the device.Catheter stretching typically occurs due to manipulation of the device against resistance.If an angiogram is performed through a damaged catheter, additional catheter damage may result.Further evaluation revealed a small hole within the stretched region.This was likely a result of the damaged region of the device being continually manipulated and was incidental to the reported event.No other devices associated with the complaint were 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 JET7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10222650
• MDR Text Key: 197280101
• Report Number: 3005168196-2020-00873
• 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: 01/01/2005,06/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F94269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• 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: 06/08/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR