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

Catalog Number	SEP5
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using indigo system separator 5 (sep5).During the procedure, the physician advanced a sep5 through an indigo system cat5 aspiration catheter (cat5).As the physician attempted to retract the sep5 through the cat5, resistance was encountered.It was observed under fluoroscopy that the tip with the "olive" did not move.As the physician continued to retract smoothly, the sep5 was successfully removed; however, it was found that the wire on the sep5 was completely damaged, lengthened, and destroyed.The tip with the "olive" was still on the wire and nothing was left in the patient.There was no mention of any damage to the cat5.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned indigo system separator 5 (sep5) delivery wire was fractured at approximately 174.0 cm from the proximal end.The wrapping wire was fractured and unraveled.Conclusions: evaluation of the returned sep5 revealed that the delivery wire and wrapping wire were fractured.If the sep5 is forcefully retracted against resistance, damage such as this may occur.The cat5 identified in the complaint was not returned for evaluation; therefore, the root cause of the resistance was unable to determined.Penumbra separators are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8828623
• Report Number: 3005168196-2019-01450
• Device Sequence Number: 19432843
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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): 06/26/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Catalogue Number: SEP5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005