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

Catalog Number	4002C2060
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/11/2018
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 5.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.The embolization coil was stretched, unraveled, and had offset coils.The sr wire was fractured on the embolization coil.The introducer sheath was not returned for evaluation.Bends were present along the length of the device.Conclusions: evaluation of the returned pc400 revealed a fractured sr wire.If the introducer sheath is ovalized due to removal from the device packaging at extreme angles, it may contribute to the experienced resistance.If the embolization coil is forcefully advanced through resistance, the embolization coil may be damaged.The sr wire typically fractures during device retraction against resistance.The introducer sheath was not returned for evaluation, therefore, the root cause of the resistance and fractured sr wire could not to be determined.Further evaluation revealed bends along the length of the device.Based on the return condition and the reported complaint, the bends were 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 in the splenic artery using penumbra coils 400 (pc400s).During the procedure, the physician successfully deployed and detached two pod coils and five pc400s in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new pc400 out of introducer sheath and into saline, the pc400 would not advance.Subsequently, the pc400 advanced out of its introducer sheath but was elongated approximately three centimeters from its distal tip; therefore, it was not used in the procedure.The procedure was completed using an additional pc400, 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: 7773515
• Report Number: 3005168196-2018-01555
• Device Sequence Number: 11257946
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (Y/N): Y
• 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): 07/13/2018
• 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: 04/30/2026
• Device Catalogue Number: 4002C2060
• Device Lot Number: F83183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• 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: 07/13/2018
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005