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

Catalog Number	400SMTSFT0408
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was undamaged and intact on its pusher assembly.The smart coil had a bend approximately 138.0 cm from the proximal end of the pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.Both smart coil introducer sheaths were reseated properly and were subsequently able to advance out of their introducer sheaths and through a demonstration microcatheter with minimal resistance.Conclusions: evaluation of the returned smart coils revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath which allows the introducer sheath to seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn proximal to the friction lock, it is likely that resistance will be experienced when attempting to advance or retract the embolization coil.The pusher assembly mid-joint being retracted proximal to the introducer sheath friction lock likely prevented the smart coil from being advanced out of its sheath during the procedure.During functional testing, the introducer sheaths were reseated properly and the smart coils were subsequently able to be advanced out of their introducer sheaths and a demonstration microcatheter with minimal resistance.The non-penumbra microcatheter was not returned for evaluation.Penumbra coils are visually 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: 3005168196-2018-02266.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance out of its introducer sheath and into a non-penumbra microcatheter; therefore, it was removed.The physician then successfully advanced another smart coil in the target vessel.Next, another smart coil would not advance out of its introducer sheath and into the microcatheter; therefore, it was removed.The procedure was successfully completed using another smart 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: 8081819
• Report Number: 3005168196-2018-02265
• Device Sequence Number: 195049
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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): 10/19/2018
• 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: 11/07/2022
• Device Catalogue Number: 400SMTSFT0408
• Device Lot Number: F80455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• 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: 10/19/2018
• Initial Report FDA Received Date: 11/16/2018
• 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
• Date Report Sent to FDA: 01/01/2005