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

Catalog Number	400SMTXSFT0104
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was kinked and had offset coil winds concentrated on its proximal end.The embolization coil was knotted on its distal end.The pusher assembly had some minor bends along its length.Conclusions: evaluation of the returned smart coils revealed embolization coil damage on their proximal end.The embolization coils were able to be advanced out of their introducer sheaths.The embolization coil damage likely contributed to resistance experienced when advancing and retracting the coils.This damage may have been a result of forcefully cycling the coil against resistance within the sheath.The root cause of the resistance experienced could not be determined.Further evaluation revealed minor bends and a knot on the distal end of the second evaluated smart coil.These damages were likely incidental to the reported failure and may have occurred during packaging for return to penumbra.Penumbra coils are visually 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 number: 3005168196-2018-01060.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula using penumbra smart coils (smart coils).During the procedure, the physician deployed and detached 18 smart coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil into the microcatheter, the smart coil would not advance past the friction lock; therefore, it was removed.It was reported that the same issue occurred with another smart coil.The procedure was completed using other 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: 7550040
• Report Number: 3005168196-2018-01061
• Device Sequence Number: 1698572
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/30/2018

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: 06/29/2022
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F77972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR