MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system separator 8 (sep8) delivery wire had the wrapping wire offset approximately 147.0 cm from the proximal end.The bulb was fractured into two pieces, and both pieces were separated from the delivery wire.Conclusions: evaluation of the returned device revealed the sep8 delivery wire was offset, and the bulb was fractured into two pieces and separated from the delivery wire.This damage likely occurred due to improper handling during use.It is possible for the sep8 bulb to become pinned against patient anatomy, tough clot burden, or other devices used in the procedure.If the bulb becomes pinned or otherwise restrained, and the sep8 is then subsequently manipulated or retracted, the bulb and delivery wire may become damaged.The fracture of the bulb into two pieces likely allowed it to separate from the delivery wire.The indigo system aspiration catheter 8 (cat8) 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 proximal superficial femoral artery (sfa) using an indigo system separator 8 (sep8).During the procedure, while using the sep8 with an indigo system aspiration catheter 8 (cat8) with no mention of resistance, the physician thought that the sep8 bulb had detached and decided to remove the sep8.Upon removal, the physician noted that the sep8 bulb was missing.Therefore, he attempted to retrieve the detached sep8 bulb by using a filter through the cat8.After the first aspiration, the physician noticed that only one component of the sep8 came out so he performed a second aspiration and was able to remove the second component.The procedure was then completed using the same cat8 and another catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7163132
• Report Number: 3005168196-2018-00025
• Device Sequence Number: 18847795
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 01/27/2019
• Device Catalogue Number: SEP8
• Device Lot Number: F67628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 01/04/2018
• 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