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

Catalog Number	400SMTSTD0820
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
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 smart coil¿s embolization coil was detached from the pusher assembly.Conclusions: visual evaluation of the returned device revealed that the smart coil¿s pet lock was broken.A broken pet lock indicates that a pull force greater than the tensile strength of the pet lock was applied to the proximal end of the pull wire.If a pull force is applied to the pull wire in this manner, the pet lock will separate, and by design the embolization coil will detach from the pusher assembly.The embolization coil was detached from the pusher assembly and therefore, the smart coil could not be functionally tested.Further evaluation revealed that the non-penumbra device was ovalized.The ovalization may have contributed to the embolization coil not being able to re-sheath during the procedure.However, the smart coil introducer sheath was not returned for evaluation and, therefore, the root cause of the complaint could not be determined.Smart coils are 100% functionally tested during in-process inspection.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 using penumbra smart coils (smart coils).During the procedure, while attempting to resheath the smart coil, the physician was unable to retract the coil completely back into its introducer sheath and subsequently, the smart coil unintentionally detached within the other manufacturer's microcatheter.The detached smart coil was removed and the procedure was completed using new smart 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: 5651951
• Report Number: 3005168196-2016-00652
• Device Sequence Number: 19052377
• Product Code: HCG
• UDI-Device Identifier: 00814548014517
• UDI-Public: 00814548014517
• 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): 04/12/2016

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: 10/19/2020
• Device Catalogue Number: 400SMTSTD0820
• Device Lot Number: F66100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2016
• Initial Report FDA Received Date: 05/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR