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

Catalog Number	SEP5
Medical Device Problem Codes	Stretched (1601); Device Damaged by Another Device (2915); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2017
Type of Reportable Event	Malfunction
Additional 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 number: 3005168196-2017-00198.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) of the left leg using an indigo system cat5 aspiration catheter (cat5) and an indigo system separator 5 (sep5).During the procedure, while attempting to advance the cat5 with the sep5 inside for the first pass, the physician experienced resistance and subsequently, the distal tip of the cat5 became kinked.Therefore, the physician was unable to advance or retract the sep5 and decided to remove the entire system and end the procedure at that point.Upon removal of sep5 from the cat5, it was observed that the sep5 was stretched due to the kinked cat5.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The indigo system separator 5 (sep5) core and platinum wires were fractured approximately 173.0 cm from the proximal end.Evaluation of the returned cat5 revealed it had multiple consecutive kinks in the distal shaft.This type of damage typically occurs due to repeated forceful advancement of the cat5 against resistance.The root cause of the initial resistance experienced by the physician could not be determined.Further evaluation revealed the sep5 core and platinum wires were fractured proximal to the bulb.This damage likely occurred due to forceful manipulation of the sep5 within the damaged cat5.Penumbra separators and 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.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6341147
• Report Number: 3005168196-2017-00199
• Device Sequence Number: 1016822
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160533
• 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,Followup
• Report Date (Section B): 01/19/2017

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: 03/29/2019
• Device Catalogue Number: SEP5
• Device Lot Number: F68692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR