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

Model Number	5MAXJETDKIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k)# that also applies to this complaint: (b)(4).The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00794.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m2 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc) and penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician advanced the 3maxc and jetd to the target vessel.While removing the 3maxc to aspirate via the jetd, the 3maxc broke distally within the jetd.Therefore, the jetd was removed with the 3maxc stuck inside it.The procedure was completed using a new 3maxc and penumbra system ace 68 reperfusion catheter (ace68).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned jetd revealed kinks on the proximal shaft.If the device is manipulated at extreme angles during use, damage such as this may occur.During functional testing, a stainless-steel mandrel was unable to be advanced through the kinks in the jetd.The kinks may have caused the 3maxc to become stuck during the procedure.Evaluation of the returned 3maxc confirmed a fracture and revealed stretching.If the device is forcefully retracted against resistance, damage such as this may occur.Manipulation of the 3maxc within the kinked jetd likely contributed to the stretch and fracture.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.This report is associated with mfr report number: 1.3005168196-2021-00794 h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11694224
• Report Number: 3005168196-2021-00793
• Device Sequence Number: 3437354
• Product Code: NRY
• UDI-Device Identifier: 00814548019802
• UDI-Public: 00814548019802
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090752
• 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): 03/23/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: 5MAXJETDKIT
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F97242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005