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

Catalog Number	400SMTXSFT0408
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock on each of the returned smart coils.The embolization coils had offset coil winds along their length.Conclusions: evaluation of the returned smart coils revealed offset coil winds along the length of each embolization coil returned.If the introducer sheath is not properly aligned within the hub, prior to advancing, resistance may be experienced and offset coil winds may result.Penumbra investigators confirmed difficulty advancing the embolization coils through their respective introducer sheaths.These offset coil winds contributed to the resistance felt during functional testing.Further evaluation revealed each pusher assembly had been retracted so that the mid-joint was proximal to the introducer sheath friction lock.If the pusher assembly is retracted too far, extreme resistance can be experienced upon subsequent attempts to advance the coil.If the coils are not rinsed in a saline bath prior to redeployment, dried blood on the embolization coil may add to any resistance experienced by the physician during advancement.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.This report is associated with mfr report numbers: 3005168196-2017-01701.3005168196-2017-01702.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil into the aneurysm using a non-penumbra microcatheter; however, the end of the coil did not fit in the aneurysm.Therefore, the physician re-sheathed the smart coil and saved it on the back table later use.The physician then placed a non-penumbra coil in the aneurysm using the same microcatheter.After that, the physician re-deploy the previously removed smart coil; however, resistance was encountered and the physician was unable to advance the coil out of its introducer sheath and into the microcatheter.Therefore, the introducer sheath containing the smart coil was removed and the physician successfully deployed and detached another smart coil in the target vessel using the same microcatheter.Thereafter, the physician advanced a new smart coil into the aneurysm using the same microcatheter; however, the end of the coil did not also fit in the aneurysm.Therefore, the physician re-sheathed the smart coil and saved it on the back table later use.The physician then placed a non-penumbra coil in the aneurysm using the same microcatheter and attempted to re-deploy the smart coil that was previously removed.However, resistance was encountered and the physician was unable to advance the coil out of its introducer sheath and into the microcatheter.Therefore, the introducer sheath containing the smart coil was removed and the physician successfully placed a non-penumbra coil in the target vessel using the same microcatheter.It was reported that the physician did not rinse both coils off in a saline bath prior to redeployment.Next, the physician experienced resistance and was unable to advance a new smart coil out of its introducer sheath and the microcatheter.Therefore, the physician removed the smart coil out of the hub of the microcatheter and attempted to advance the coil by itself; however, resistance was encountered.It was reported that it took a lot of force to get the coil out of its introducer sheath and the coil had a ¿grinding, gritty¿ feeling.In addition, the smart coil was not advancing easily like it should.Therefore, the smart coil was set aside and the procedure was completed using a non-penumbra coil.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: 6902207
• Report Number: 3005168196-2017-01700
• Device Sequence Number: 718651
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/07/2017

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: 01/12/2022
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F73773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR