MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER; NRY

Model Number 5MAXJET7KIT-B

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-01210, 3005168196-2020-01211.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using penumbra system jet 7 reperfusion catheters (jet7s).During the procedure, three jet7 distal tips became damaged.However, it is unknown in which order the three jet7 distal tips were damaged, broken and stretched respectively.Also, it was unknown if the jet7 that expanded occurred on the back table or within the patient.Subsequently, the jet7s were not used for the remainder of the procedure.The physician continued with the procedure and used a fourth jet7 but was unable to successfully aspirate the clot.The procedure ended at this point.There was no report of an adverse effect to the patient.No additional information is available.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2020-01210.2.3005168196-2020-01211.

• Brand Name: PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10410373
• MDR Text Key: 203092286
• Report Number: 3005168196-2020-01209
• 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: 01/01/2005,07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: 5MAXJET7KIT-B
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F94945
• Was Device Available for Evaluation?: No
• 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: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR