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

Catalog Number	400SMTSTD0725
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the penumbra smart coil (smart coil) pusher assembly.The pusher assembly was bent in multiple locations throughout its length.The introducer sheath was re-loaded backwards on the pusher assembly.The embolization coil was detached from the pusher assembly, had the proximal constraint sphere intact, and was stretched near its proximal end.The distal end of the embolization coil was covered in dried blood.The outer diameter (od) of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the returned device revealed the pet lock was broken and the embolization coil was detached from the pusher assembly.A broken pet lock indicates that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the coil.If the pet lock becomes broken it will, by design, allow the embolization coil to detach.Further evaluation revealed the introducer sheath was re-loaded backwards onto the pusher assembly.If the introducer sheath is re-loaded backwards, resistance will likely be experienced upon attempting to re-advance the embolization coil out of the introducer sheath.The broken pet lock and backwards-loaded introducer sheath were likely incidental and may have occurred after the smart coil was withdrawn from the non-penumbra microcatheter.Further evaluation revealed the pusher assembly was kinked in multiple locations and the embolization coil was stretched.This damage may have occurred due to forceful manipulation of the smart coil against resistance.The od of the embolization coil was measured and found to be within specification.Since the embolization coil was detached from the pusher assembly, the smart coil could not be functionally tested.The root cause of the initial resistance experienced by the physician could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils 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 in the cerebral artery using penumbra smart coils (smart coils).During the procedure, while attempting to advance the first smart coil of the procedure through a non-penumbra microcatheter, the physician experienced resistance.However, the physician advanced and retracted this smart coil multiple times despite the resistance and placed it in the aneurysm.After deploying this smart coil in the aneurysm, the physician decided to remove the smart coil from the patient in order to avoid any issue.The procedure was completed using a new smart coil, the same non-penumbra microcatheter, and additional coils.In addition, the physician reported using a rotating hemostasis valve and maintaining continuous flush.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: 6117557
• Report Number: 3005168196-2016-01657
• Device Sequence Number: 13664053
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2016

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: 06/13/2021
• Device Catalogue Number: 400SMTSTD0725
• Device Lot Number: F70115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR