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

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The broken tip of sep8 remained in the body and the rest was disposed of.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an occluded graft using an indigo separator separator 8 (sep8).It was reported that the graft was occluded after a stent device had been placed in the patient during a previous procedure and a bare metal stent was placed near the proximal anastomosis of the graft; however, the stent had migrated during to the distal anastomosis.During the current procedure to treat the occluded graft, the physician used the sep8 with an indigo system aspiration catheter 8 (cat8) to successfully removed lot of thrombus from the graph by working proximal to distal.The physician was advancing and retracting the sep8 in and out of the cat8 towards the distal end of the graft near where the bare metal stent had migrated to clear thrombus.During this process, the sep8 bulb appeared to have caught onto the bare metal stent and came off when the physician pulled the sep8 wire back.The physician then attempted to aspirate the detached bulb out but was unsuccessfully.Therefore, the physician removed the sep8 from the patient and the detached sep8 bulb stayed lodged in the stent device in the patient.Next, the physician placed a stent graft over the bulb to keep it in place; this stent graft was intended to be placed at this location at the beginning of the procedure since there was a need to reline the graft because of the previously migrated stent.Following the stent graft placement, the physician left another manufacturer¿s infusion catheter in the patient in order to try and dissolve the remaining clot in the graft.There was no report of adverse effect to the patient.The physician who saw the patient the following day does not believe that the bulb left behind in the patient¿s body would cause the patient harm as it was covered with the stent graft.It was also noted that the clot was completely resolved and lytics were discontinued.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6122641
• Report Number: 3005168196-2016-01694
• Device Sequence Number: 1248810
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: SEP8
• Device Lot Number: F67242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR