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

Catalog Number	4002C1660
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	12/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked approximately 45.0, 66.0, and 89.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and the coil winds were ovalized and offset.The introducer sheath was ovalized approximately 106.0 cm from the distal tip.Conclusions: evaluation of the first returned pc400 revealed that the pusher assembly was fractured and kinked.The fractured pusher assembly likely occurred due to an attempt to manual detachment the pc400 during the procedure as mentioned in the complaint.Further evaluation of the pc400 revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return.The slightly tortuous anatomy likely contributed to the detachment issue during the procedure.Evaluation of the returned handle revealed that the handle was functional.The handle was functionally tested on the handle fixture for pull force and throw distance.The handle passed both test for pull force and throw distance without an issue.The root cause of the handle detachment issue could not be determined.Evaluation of the second returned pc400 revealed that the embolization coil winds were offset and flattened.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such as offset and flattened coil winds may occur.Tortuous patient anatomy likely contributed to the reported resistance.Further evaluation of the returned device revealed that the pusher assembly was kinked and the introducer sheath was ovalized.This damage was likely incidental and may have occurred while packaging the device for return to penumbra.The lantern referred to in the complaint was not returned 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 numbers: 3005168196-2018-00251, 3005168196-2018-00253.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac vein using penumbra coils 400 (pc400s), a pod8 and penumbra coil 400 detachment handles (handles).It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician placed eight pc400s and three non-penumbra coils in the target vessel using a lantern delivery microcatheter (lantern).The physician then advanced a new pc400 (f66239) in the target vessel using the same lantern and attempted to detach it using a handle; however, the coil failed to detach.After two to three failed attempts, the physician manually bent the coils pusher assembly and attempted to manually detach it; however, the pc400 would not detach.Therefore, it was removed.The procedure continued using eight additional pc400s and two non-penumbra coils.While attempting to advance a new pc400 (f70755) through the lantern, the physician experienced resistance at the middle of the lantern and therefore, the pc400 was removed.The physician then decided to use a pod8; however, resistance was encountered again and the pod8 was removed.The procedure was completed additional coils, a new handle 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: 7235879
• Report Number: 3005168196-2018-00252
• Device Sequence Number: 16398185
• Product Code: HCG
• UDI-Device Identifier: 00814548010724
• UDI-Public: 00814548010724
• 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
• Type of Report: Initial
• Report Date (Section B): 01/05/2018

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: 07/19/2024
• Device Catalogue Number: 4002C1660
• Device Lot Number: F70755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR