MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number	400SMTSTD1160
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations throughout its length.The embolization coil was detached from the pusher assembly, the pe fibers were fractured, and the proximal constraint sphere was inside the distal detachment tip (ddt).The embolization coil was unwound with dried blood trapped within.Evaluation of the returned device revealed the embolization coil was detached from the pusher assembly and the pe fibers were fractured.Fracture of the pe fibers typically occurs due to forceful retraction of the smart coil against resistance, and will allow the embolization coil to detach.Further evaluation revealed the embolization coil was unwound and the pusher assembly was kinked in multiple locations.The unwinding of the detached embolization coil likely occurred during attempts to retrieve the coil with a snare.The kinks observed in the pusher assembly were likely incidental and may have occurred during packaging for return to penumbra.Penumbra coils and catheters 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 coil embolization procedure to treat an intra-cerebral aneurysm using penumbra smart coils (smart coil).During the procedure, while attempting to retract a smart coil into a non-penumbra microcatheter for repositioning, the smart coil unintentionally detached outside of the microcatheter and in the aneurysm.The physician then used a snare device to remove the detached smart coil, but the smart coil fragmented into pieces during the attempt to snare.Majority of the coil was removed by the snare device.However, some fragments remained outside the aneurysm inside the patient¿s body.The procedure then continued using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7104779
• Report Number: 3005168196-2017-02190
• Device Sequence Number: 1934270
• Product Code: HCG
• UDI-Device Identifier: 00814548014425
• UDI-Public: 00814548014425
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 02/28/2022
• Device Catalogue Number: 400SMTSTD1160
• Device Lot Number: C00991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/11/2017
• 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