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

Catalog Number	400SMTXSFT3H08
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 116.0, 128.0, 136.5 and 138.0 cm from the proximal end.The pusher assembly was retracted proximal to the introducer sheath mid-joint.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first evaluated smart coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter is smaller than the rest of the introducer sheaths which allows the introducer sheath to seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn proximal to the introducer sheath friction lock, it is likely that resistance will be experienced when attempting to advance or retract the embolization coil.The pusher assembly being retracted proximal to the introducer sheath friction lock likely contributed to the resistance prior to the pusher assembly becoming kinked.During the functional test, resistance was encountered while attempting to advance the smart coil out of its introducer sheath and into a demonstration microcatheter.The smart coil was able to be advanced out of its introducer sheath and through a demonstration microcatheter without an issue.Evaluation of the second evaluated smart coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter is smaller than the rest of the introducer sheaths which allows the introducer sheath to seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn proximal to the introducer sheath friction lock, it is likely that resistance will be experienced when attempting to advance or retract the embolization coil.The pusher assembly being retracted proximal to the introducer sheath friction lock likely contributed to the resistance prior to the pusher assembly becoming kinked.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath and the smart coil could not be advanced any further.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2018-02221.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).It was noted that the patient¿s anatomy was mildly tortuous, calcified and narrowing vessels.During the procedure, the physician placed a non-penumbra coil and four smart coils in the target vessel using a non-penumbra microcatheter.The physician was then unable to advance two other smart coils out of their introducer sheaths and into the microcatheter; therefore, they were removed.The procedure was completed using six additional 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: 8057346
• Report Number: 3005168196-2018-02222
• Device Sequence Number: 16557665
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• Combination Product (Y/N): Y
• 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): 10/11/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F77666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/09/2018
• 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
• Patient Weight: 73
• Date Report Sent to FDA: 01/01/2005