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

Model Number	400SMTXSFT0408
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician implanted one smart coil and three non-penumbra coils into the target vessel using the microcatheter.It was reported that the next smart coil would not advance from its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using nine additional smart coils, twenty-one non-penumbra coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 136.5 cm from the proximal end.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and detached from the pusher assembly.Conclusions: evaluation of the returned smart coil revealed a fractured pusher assembly and detached embolization coil.Further evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Subsequently, if a kinked pusher assembly is further manipulated, the kink may worsen to a fracture and the embolization coil will detach.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9922257
• Report Number: 3005168196-2020-00502
• Device Sequence Number: 3296151
• Product Code: HCG
• UDI-Device Identifier: 00814548015392
• UDI-Public: 00814548015392
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020
• 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: 08/20/2022
• Device Model Number: 400SMTXSFT0408
• Device Catalogue Number: 400SMTXSFT0408
• Device Lot Number: F78761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005