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

Catalog Number	400SMTXSFT0104
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly was retracted such that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was tightly wound inside the introducer sheath.The pusher assembly was kinked approximately 49.0, 68.0, and 120.0 cm from the proximal end.During functional analysis, the introducer sheath was re-loaded onto the pusher assembly and some stickiness was experienced while reloading the device.Furthermore, the smart coil was unable to be advanced inside its introducer sheath.A demonstration introducer sheath was then loaded onto the returned pusher assembly and a demonstration smart coil was advanced through the returned introducer sheath but the observed stickiness could not be recreated in both instances.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly was retracted proximal enough such that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced upon attempting to advance the coil.Further evaluation revealed stickiness inside the introducer sheath and a kinked pusher assembly.The kinks were likely incidental and may have occurred during packaging for return to penumbra.The returned device components were used with corresponding demonstration components but the observed stickiness on the returned devices could not be recreated.Therefore, root cause of the stickiness inside the returned sheath could not be determined.The non-penumbra microcatheter 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 to treat a ruptured aneurysm using penumbra smart coils (smart coils).During the procedure, the physician placed several coils into the patient using a non-penumbra microcatheter.While attempting to advance a new smart coil through the microcatheter, the physician was able to advance the coil into the microcatheter but then the coil stopped advancing after several centimeters and would not advance any further.Therefore, the smart coil was removed and the procedure was completed using additional coils.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: 7179340
• Report Number: 3005168196-2018-00104
• Device Sequence Number: 1342618
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/13/2017

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: 12/18/2021
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F73220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR