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

Catalog Number	400SMTSFT0306
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly was kinked in multiple locations along its length.The smart coil was successfully detached and, therefore, no functional analysis was performed.Conclusions: evaluation of the returned sch1 revealed no damage to the handle.The handle was tested using the handle fixture and functioned without an issue.Furthermore, the handle was used to detach a demonstration smart coil, and the pull wire was easily removed from the funnel.The inner diameter (id) of the sch1 funnel was measured to be within specification.Evaluation of the returned smart coil revealed that the pusher assembly was kinked.This damage was likely incidental, and may have occurred during packing the device for return.The root cause of the difficulty experienced by the physician could not be determined.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are functionally tested during incoming inspection by quality.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: 3005168196-2017-00923, 3005168196-2017-00924.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (sch1).During the procedure, the physician successfully deployed and detached a smart coil using the sch1, however the physician experienced difficulty removing the proximal end of the pusher wire from the sch1.After multiple attempts manipulating the wire and sch1, the pusher wire was removed from the sch1.This occurred with two additional smart coils, however the procedure was completed using the three smart coils and the sch1.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: 6648945
• Report Number: 3005168196-2017-00922
• Device Sequence Number: 19094977
• Product Code: HCG
• UDI-Device Identifier: 00814548015040
• UDI-Public: 00814548015040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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: 07/14/2021
• Device Catalogue Number: 400SMTSFT0306
• Device Lot Number: F70649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1