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

Catalog Number	5MAXJETDKIT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 510(k) # that also apply to this complaint: k133317.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 or Problem Description
The patient underwent a thrombectomy procedure in the m1 of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd).During the procedure, while removing the jetd with a penumbra system 3d revascularization device ((b)(4)), the physician noticed that the proximal end of the jetd was split.The thrombus was removed with the jetd and (b)(4) and, therefore, the procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the jetd was kinked approximately 23.0 cm from the hub.During functional testing, a 0.064¿ stainless steel mandrel was unable to advance past the proximal kink in the returned jetd.Conclusions: evaluation of the returned jetd revealed a kink on the proximal shaft.If the device is advanced against resistance or manipulated at extreme angles, damage such as a kink may occur.The psr3d identified in the complaint was not returned for evaluation.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 JETD REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8679382
• Report Number: 3005168196-2019-01110
• Device Sequence Number: 16598271
• Product Code: NRY
• UDI-Device Identifier: 00814548019741
• UDI-Public: 00814548019741
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 05/09/2019
• 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: 01/14/2022
• Device Catalogue Number: 5MAXJETDKIT
• Device Lot Number: F87966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005