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

Catalog Number	400SMTSFT3H08
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
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 had multiple kinks approximately 171.0 cm from the proximal end, and blood was observed inside the pusher assembly lumen.The embolization coil was intact with the pusher assembly and had offset coil winds and gaps, and the pull wire was inside the distal detachment tip (ddt).The embolization coil had offset coil winds and gaps near its proximal end.Conclusions: evaluation of the returned penumbra smart coil detachment handle (handle) revealed that it passed for both pull force and throw distance when functionally tested.Evaluation of the returned smart coil revealed that the pet lock was broken and the embolization coil was intact with the pusher assembly.A broken pet lock indicates that a pull force was applied to the proximal end of the pull wire, typically in an attempt to detach the coil.Further evaluation revealed that the distal section of the pusher assembly was kinked and the embolization coil had offset coil winds and gaps.This damage may have occurred due to forceful manipulation during positioning within patient anatomy.The pusher assembly kinks likely caused a buildup of friction between the pull wire and the inner pusher assembly lumen, which likely caused a buildup of friction that overcame the force delivered by the handle.The blood observed inside the pusher assembly lumen may have also contributed to the buildup of friction in the pusher assembly lumen.Further evaluation revealed the non-penumbra microcatheter was kinked near the hub.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a non-penumbra sheath into the internal cerebral artery (ica), then advanced a non-penumbra microcatheter through the sheath and into the aneurysm.Next, the physician deployed a smart coil into the aneurysm but was unable to detach the coil using the handle.After three failed attempts to detach the smart coil, the physician removed the coil and completed the procedure using another coil without further issues.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: 6732528
• Report Number: 3005168196-2017-01221
• Device Sequence Number: 1371369
• Product Code: HCG
• UDI-Device Identifier: 00814548017013
• UDI-Public: 00814548017013
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

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: 08/01/2021
• Device Catalogue Number: 400SMTSFT3H08
• Device Lot Number: F70923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1