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

Catalog Number	400SMTSTD0830
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2018
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pusher assembly.The embolization coil was undamaged and intact with the pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.Kinks and bends were present along the length of the device.The smart coil was attempted to be advanced through its introducer sheath.Moderate resistance was experienced as the pusher assembly mid-joint was advanced past the introducer sheath friction lock.No resistance was experienced after the friction lock had passed over the mid-joint.Conclusions: evaluation of the returned smart coil revealed 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 allowing it to seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully retracted proximal to the friction lock, it is likely that resistance will be experienced when attempting to advance or retract the embolization coil.During functional testing, the pusher assembly mid-joint was advanced past the friction lock with moderate resistance.After the mid-joint was past the friction lock, no resistance was experienced when advancing the coil further through the introducer sheath.Further evaluation revealed kinks and bends along the device.Based on the return condition and the reported complaint, the bends and kinks are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (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 procedure was completed using a new smart coil 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: 7873242
• Report Number: 3005168196-2018-01798
• Device Sequence Number: 228324
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2018
• 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: 09/21/2021
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F71734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• 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: 08/14/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005