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

Catalog Number	SEP5-A
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/10/2016
Type of Reportable Event	Serious Injury
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: 3005168196-2016-00456.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal artery using an indigo system separator 5 (sep5) and an indigo system cat 5 aspiration catheter (cat5).During the procedure, while removing thrombus, the proximal end of the sep5 fractured in the patient and the cat5 became kinked.The kinked cat5 was removed from the patient.The physician attempted to remove the fractured portion of the sep5 from the patient by using another catheter.The physician reported that the fractured portion of the sep5 was removed as it was no longer visible under fluoroscopy; however, the physician could not identify the fractured piece outside of the catheter.The procedure continued with manual aspiration using another manufacturer's catheter and a new cat5; however, complete recanalization of the vessel was not achieved.The patient status is unknown.
Additional Manufacturer Narrative
Results: the distal tip of the indigo system separator 5 (sep5) was fractured approximately 174.3 cm from the proximal end of the delivery wire.The sep5 was kinked in multiple locations along the delivery wire.Conclusions: evaluation of the returned device revealed that the distal tip of the sep5 was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted inside a kinked device, the core wire of the sep5 may fracture, and damage such as this may occur.The sep5 delivery wire was kinked in multiple locations along the delivery wire.These kinks were likely incidental, while packaging the device for returned.The kinked cat5 mention in the complaint was not returned for evaluation.The reported kink in the cat5 likely contributed to the sep5 bulb fracture.Sep5s and cat5s are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
Correction: in the second sentence a correction was made from "proximal end" to distal end.The corrected sentence reads as follows: during the procedure, while removing thrombus, the distal end of the sep5 fractured in the patient and the cat5 became kinked.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5552857
• Report Number: 3005168196-2016-00455
• Device Sequence Number: 272774
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): N
• PMA/510(K) Number: K121917
• 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): 03/10/2016

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: 10/31/2017
• Device Catalogue Number: SEP5-A
• Device Lot Number: F46427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 05/13/2016
• 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: 62 YR