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

Catalog Number	4002C1450
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
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 fractured approximately 5.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the returned device revealed that the pc400 pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully handled during removal of the introducer sheath, it may become kinked.If an attempt is then made to straighten the kink, damage such as a fracture may occur.The px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation.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, while attempting to retract a pc400 introducer sheath from the pusher assembly upon advancing the pc400 into a px slim delivery microcatheter (px slim), the pc400 pusher assembly became kinked.Anticipating that the pc400 might have unintentionally detached, the physician removed the pc400.It was reported that the physician did not mention resistance while attempting to retract the pc400 introducer sheath and that the pc400 was still attached to its pusher assembly after removal.The procedure was completed using a new pc400 and the same px slim.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: 6870341
• Report Number: 3005168196-2017-01601
• Device Sequence Number: 873128
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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: 10/19/2024
• Device Catalogue Number: 4002C1450
• Device Lot Number: F72419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1