MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER; NRY

Catalog Number	PSC054
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Result: the penumbra system 5max reperfusion catheter (5max) was fractured and unraveled approximately 107.5 cm from the hub.The 5max was ovalized in two locations near the hub.Conclusion: evaluation of the returned device confirmed that the 5max distal shaft was fractured.If the 5max is forcefully withdrawn against resistance this type of damage may occur.Further evaluation revealed that the 5max was ovalized in two locations near the hub.If the catheter is manipulated at extreme angles during use, this damage may occur.The non-penumbra sheath mentioned in the complaint was not 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 5max reperfusion catheter (5max).During the procedure, using a non-penumbra sheath, the 5max broke into two pieces approximately 10cm from the distal tip in the right internal carotid artery (ica) of the patient.The physician made no attempt to retrieve the distal tip of the 5max from within the patient, and the procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6300945
• Report Number: 3005168196-2017-00140
• Device Sequence Number: 455074
• Product Code: NRY
• UDI-Device Identifier: 00814548012742
• UDI-Public: 00814548012742
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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: Physician
• Device Expiration Date: 07/21/2019
• Device Catalogue Number: PSC054
• Device Lot Number: F70749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR