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

Catalog Number	SEP5
Medical Device Problem Codes	Material Frayed (1262); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2016-01395.
Event or Problem Description
The patient was undergoing a thrombectomy procedure treating an occluded bypass graft using a penumbra system ace 64 reperfusion catheter (ace 64) and an indigo system separator 5 (sep5).During the procedure, the physician advanced a non-penumbra sheath along with a guidewire to the target vessel.While crossing the proximal cap of the graft, the physician experienced difficulty but was able to successfully advance the guidewire.However, the physician did not want to lose guidewire access and advanced a second guidewire so that a buddy system could be used while using the penumbra system.The physician then advanced the ace 64 through the sheath; however, while advancing the ace 64,the physician experienced resistance noticed that the tip of the catheter became kinked.It is unclear when the kink occurred.Consequently, the physician was unable to advance a separator wire through this kinked ace 64 and therefore the ace 64 was removed.Next, the physician advanced an indigo system aspiration catheter 5(cat5) over the guidewire then removed the guidewire before advancing the sep5 through the cat5.As the aspiration was initiated, the physician mentioned experiencing resistance with the sep5 and the sep5 was not advancing as smoothly as it initially did.Therefore, the sep5 was removed and upon inspection, the physician noticed that the sep5 wire was frayed.The procedure was therefore successfully completed using a new sep5 and the same cat5.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the indigo system separator 5 (sep5) core wire was fractured approximately 173.0 cm from the proximal end.Conclusions: evaluation of the returned device revealed that the sep5 core wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully withdrawn against resistance, damage such as this may occur.The tortuous anatomy may have contributed to the resistance experienced when advancing and retracting the guidewires, ace 64, and sep5.The non-penumbra sheath, ace 64, cat5, and non-penumbra guidewires mentioned in the complaint were not returned for evaluation.All 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.This report is associated with mfr report numbers: 3005168196-2016-01395.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5992141
• Report Number: 3005168196-2016-01396
• Device Sequence Number: 13927326
• Product Code: DXE
• UDI-Device Identifier: 00814548013329
• UDI-Public: 00814548013329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K121917
• 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,Followup
• Report Date (Section B): 09/01/2016

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: 05/31/2018
• Device Catalogue Number: SEP5
• Device Lot Number: F64165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2016
• Supplement Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR