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

Catalog Number	4002C2860
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly was kinked approximately 5.0 and 10.0 cm from the proximal end and fractured approximately 25.0 cm from the proximal end.The embolization coil and the segment of the pusher assembly distal to the fracture were not returned for evaluation.Conclusion: evaluation of the returned device revealed the pusher assembly was kinked and fractured.This type of damage typically occurs due to forceful manipulation of the pc400 during insertion into a microcatheter.If the pusher assembly becomes fractured, it may allow the pull wire to retract out of the distal detachment tip (ddt), which will in turn allow the embolization coil to detach.The non-penumbra microcatheter mentioned in the complaint, the embolization coil, and the segment of the pusher assembly distal to the fracture were not returned for evaluation.Penumbra coils are 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 (pc400).During the procedure, while in use with another manufacturer's microcatheter, a pc400 unintentionally detached from its pusher assembly.The procedure was completed using additional pc400 as well as other manufacturer's coils.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: 5884653
• Report Number: 3005168196-2016-01184
• Device Sequence Number: 1326360
• Product Code: HCG
• UDI-Device Identifier: 00814548011981
• UDI-Public: 00814548011981
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: 08/31/2021
• Device Catalogue Number: 4002C2860
• Device Lot Number: F37888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2016
• Supplement Report FDA Received Date: 09/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 65