MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 5; DXE

Catalog Number	SEP5
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the core wire was fractured approximately 173.0 cm from the proximal end of the pusher wire.The platinum wire was unwound but intact, and the bulb was intact with the platinum wire.The pusher wire had kinks in multiple locations.Conclusions: evaluation of the returned device revealed the core wire was fractured and the platinum wire was unwound, but the sep5 bulb was intact with the platinum wire and not separated from the rest of the sep5.Fracture of the core wire may have occurred due to forceful retraction of the sep5 against resistance, and allowed the platinum wire to unwind.The root cause of the resistance experienced by the physician could not be determined.Further evaluation revealed the pusher wire was kinked in multiple locations.This damage was likely incidental and may have occurred during packaging for return to penumbra.The cat5 mentioned in the complaint was not returned for evaluation.Penumbra separators 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 in the branchial artery using an indigo system separator 5 (sep5).During the procedure, the physician noticed that the tip of the sep5 was not moving in conjunction with proximal end of the sep5 within the indigo system aspiration catheter 5 (cat5); therefore the cat5 was removed with the sep5 inside.Upon removal, the physician found that the distal tip of the sep5 was stretched and unusable.The procedure was therefore completed using a new sep5.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6556026
• Report Number: 3005168196-2017-00718
• Device Sequence Number: 11011612
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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
• Report Date (Section B): 03/31/2017

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: 06/21/2019
• Device Catalogue Number: SEP5
• Device Lot Number: F70220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR