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

Catalog Number	400SMTSTD0830
Medical Device Problem Codes	Separation Failure (2547); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-00939, 3005168196-2017-00940.The coil was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a basilar bifurcation aneurysm using penumbra smart coils (smart coils) and penumbra smart coil detachment handles (sch1s).During the procedure, the physician had difficulty detaching a smart coil using a sch1.It was reported that the ¿t¿ mark was in place for the detachment; however, the smart coil would not detach.After three failed attempts, a new sch1 was opened; however, the smart coil would still not detach.Therefore, the smart coil was manually detached.The procedure was completed using a total of fifteen coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the initial mfr report indicated that the device was not available for return due to the embolization coil being implanted; however, the pusher assembly was returned on 06/06/2017.Additional information was received on 07/03/2017 following receipt of the returned devices confirming that this is a duplicate complaint and was also reported under report number 3005168196-2017-01038.Therefore, please refer to mfr report number 3005168196-2017-01038 and its associated follow-up.Results: the pet lock was broken on the returned smart coil pusher assembly.One of the pusher assemblies was kinked in multiple locations.The polymer section of the smart coil pusher assembly displayed a similar bend.Conclusions: evaluation of the returned smart coil pusher assemblies revealed bends in their distal polymer sections.These curves are likely a result of positioning within tortuous anatomy.These bends suggest that the subject region of patient anatomy was tortuous.If the smart coil is placed in tortuous anatomy, friction can build up inside the hypotube of the pusher assembly, overcoming the force able to be applied by the detachment handle, which can contribute to difficulty detaching the embolization coils.The pet lock was broken on the proximal end of each of the pusher assemblies.A broken pet lock indicates that a pull force was applied to the proximal end of the pull wire, typically in attempt to detach the coil.The penumbra smart coil detachment handle (sch1) returned was tested, performed within penumbra specification, and displayed no visible damage.Further evaluation revealed one of the pusher assemblies was kinked in multiple locations.This damage was likely incidental and occurred during packaging for return to penumbra facilities.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 numbers: 3005168196-2017-00939, 3005168196-2017-00940.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6641762
• Report Number: 3005168196-2017-00938
• Device Sequence Number: 10789482
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 10/05/2020
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F65962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR