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

Catalog Number	4002C1245
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
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 1.5 and 75.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.During the functional test, resistance was encountered while advancing the kinks in the pusher assembly through the demonstration microcatheter; however, the pc400 was advanced completely through the microcatheter and out of the distal tip.The microcatheter identified in the complaint was not returned and therefore, the root cause of the initial resistance could not 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery using penumbra coils 400 (pc400s).During the procedure, the physician deployed and detached three ruby coils in the target vessel using a non-penumbra microcatheter.While attempting to advance a pc400 through the microcatheter, the physician experienced resistance in the middle of the microcatheter and therefore, the pc400 was removed.The procedure was completed using another pc400, eight ruby coils and the same microcatheter.It was reported that the surface of the microcatheter was rough.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: 7799768
• Report Number: 3005168196-2018-01633
• Device Sequence Number: 19345319
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2018
• 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: 01/06/2026
• Device Catalogue Number: 4002C1245
• Device Lot Number: F81330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• 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: 07/22/2018
• Initial Report FDA Received Date: 08/20/2018
• 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