MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C0720
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	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 24.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.The proximal end of the embolization coil was stuck inside the friction lock on the proximal end of the introducer sheath.Conclusions: evaluation of the returned device revealed that the embolization coil had offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.The root cause of the resistance could not be determined.Further evaluation of the returned device revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This damage likely occurred after the procedure.Evaluation of the returned device revealed that the device was kinked.If the device is forcefully advanced against resistance, damage such as this may occur.The root cause of resistance could not be determined.Further evaluation of the returned device revealed that the sr wire was fractured and the embolization coil was detached from its pusher assembly.If the proximal end of the embolization coil is forcefully retracted against resistance through the introducer sheath friction lock, damage such as this may occur.The introducer sheath¿s friction lock id is smaller than the rest of the sheath.The id of the friction lock is slightly larger than the proximal end of the embolization coil.However, if the coil is retracted through the friction lock, resistance may be encountered, and will likely result in a sr wire fracture.Evaluation of the returned handle revealed that the handle was functional.The handle was functionally tested on the handle fixture for pull force and was within specification.The lantern referred to in the complaint was returned to penumbra for evaluation.Penumbra coils and catheters 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 number: 3005168196-2018-00744.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery using penumbra coils 400 (pc400¿s).It was noted that the patient¿s anatomy was tortuous.During the procedure, while attempting to advance a pc400 through a lantern delivery microcatheter (lantern), the physician experienced resistance approximately 10 centimeters from the distal tip of the lantern and the pc400 would not advance; therefore, it was removed.The physician then attempted to advance a new pc400 through lantern; however, resistance was encountered at the same position and pc400 would not advance further.Therefore, the pc400 was removed and the procedure was completed using other coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7412348
• Report Number: 3005168196-2018-00745
• Device Sequence Number: 16459835
• Product Code: HCG
• UDI-Device Identifier: 00814548010540
• UDI-Public: 00814548010540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 07/18/2024
• Device Catalogue Number: 4002C0720
• Device Lot Number: F70728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1