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	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 42.0, 45.0, 51.0 and 132.0 cm from the proximal end.The embolization coil was detached from its pusher assembly, inside its introducer sheath with coagulated blood and had offset coils winds.The pc400 was detached from its pusher assembly and, therefore, the pc400 could not be functionally tested.Conclusions: evaluation of the returned pc400 revealed that the embolization coil was detached from its pusher assembly and the pusher assembly was kinked.If the device is forcefully retracted against resistance, the polymer section of the pusher assembly may elongate beyond the reach of the pull wire inside the ddt, resulting in the embolization coil detaching from its pusher assembly.Coagulated blood was present along the length of the detached embolization coil within its introducer sheath.This blood may have contributed to resistance when being re-sheathed and may have contributed to the elongation of the polymer section of the pusher assembly.Further evaluation of the returned pc400 revealed that the pusher assembly was kinked.These kinks may have occurred due to forceful advancement against resistance.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation, therefore, the root cause of this 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.This report is associated with mfr report number: 3005168196-2018-01540.
Event or Problem Description
The patient was undergoing a retrograde transvenous coil embolization with balloon obstruction coil using a penumbra coils 400 (pc400s).During the procedure, the physician experienced resistance while using the first pc400; however, the pc400 was able to be deployed and detached in the target location using a non-penumbra microcatheter.While advancing a new pc400 through the microcatheter, the physician experienced resistance at about 2cm from the distal tip of the microcatheter; therefore, the pc400 was removed.The procedure was completed using another treatment method.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: 7769870
• Report Number: 3005168196-2018-01539
• Device Sequence Number: 173805
• 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): 07/10/2018
• 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: 01/20/2026
• Device Catalogue Number: 4002C1245
• Device Lot Number: F81550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• 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: 07/10/2018
• Initial Report FDA Received Date: 08/09/2018
• 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