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

Catalog Number	400SMTXSFT0104
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the smart coil pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds near its proximal end.During functional analysis, resistance was observed when advancing the coil out of its introducer sheath.Furthermore, the smart coil could not be advanced into a demonstration microcatheter.Conclusions: evaluation of the first smart coil revealed the embolization coil was severely stretched on the proximal end.This damage likely occurred due to return packaging conditions.The return packaging-related damage observed on the embolization coil prevented the smart coil from being advanced or retracted through its introducer sheath.Due to the return packaging-related damage, the root cause of the inability to advance the first smart coil during the procedure could not be determined.Evaluation of the second, third, and fourth smart coils revealed that the embolization coils had offset coil winds.If the introducer sheath is not properly aligned in the hub of the microcatheter and the smart coil is forcefully advanced, resistance may be experienced, and coil winds may become offset.The offset coil winds caused resistance when advancing the smart coils during functional analysis.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.This report is associated with mfr report numbers: 3005168196-2017-01182, 3005168196-2017-01184, 3005168196-2017-01185.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, while attempting to advance four smart coils out of their introducer sheaths and into the non-penumbra microcatheter, the physician encountered resistance and was unable to advance the coils out.Therefore, the introducer sheaths containing the coils were removed.It was also reported that the ruby coils could not be advanced out of their introducer sheaths while on the back table and resistance was encountered with at least one of the coils.The procedure was successfully completed using new smart coils 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: 6712821
• Report Number: 3005168196-2017-01183
• Device Sequence Number: 19272490
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/15/2017

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: 12/18/2021
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F73220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR