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

Catalog Number	400SMTXSFT2H04
Medical Device Problem Codes	Failure to Fold (1255); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: both smart coils were returned unlabeled and were unable to be distinguished.The device investigation will identify the devices as the first and second smart coil.Both smart coils pet locks were intact on the proximal ends of their pushers.Both embolization coils were intact with their pusher assemblies.Both pusher assemblies were bent and curled in multiple areas throughout the length of the pusher assembly.The first smart coil embolization coil was undamaged while the second smart coil embolization coil had stretched and offset coil winds.The first smart coil pusher assembly was approximately 186.0 cm long and the second smart coil pusher assembly was approximately 185.5 cm long.Conclusions: evaluation of the returned smart coils revealed kink and bend damage along the length of both pusher assemblies.The root cause of these damages could not be determined.Both pusher assemblies were measured to be within specification.Further evaluation revealed the second smart coil embolization coil had stretched and offset coil winds.Based on the reported complaint this coil damage is likely incidental to the complaint.Based on the return condition, some of the bends and curls are likely incidental to the complaint, and may have occurred during packaging for return to penumbra.The root cause of the curls, bends, and stretching was unable to be determined.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: 3005168196-2018-02091; 3005168196-2018-02093.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica)/ophthalmic artery using penumbra smart coils (smart coils).It was noted that the patient¿s aneurysm had an irregular shape.During the procedure, three smart coils would not conform to the aneurysm and kept falling out into the parent vessel.Upon removing the smart coils, the physician noticed the smart coils pusher assemblies were curled and stretched.The physician also commented that the pusher assemblies were very flimsy.The procedure was completed without placing any coils in the aneurysm.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: 7996012
• Report Number: 3005168196-2018-02092
• Device Sequence Number: 1387278
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 00814548015323
• Combination Product (Y/N): Y
• Initial Reporter State: SD
• 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): 09/25/2018
• 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: 11/30/2022
• Device Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F80833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• 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: 09/25/2018
• Initial Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005