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

Catalog Number	4002C0620
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
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 bent in multiple locations throughout its length.The introducer sheath was kinked approximately 70.0 cm from its proximal end and ovalized approximately 72.0 cm from its proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the introducer sheath was kinked and ovalized.This damage may have occurred due to forceful handling of the pc400 during removal from the packaging or insertion into the px slim.The damage observed on the introducer sheath likely contributed to the resistance experienced by the physician.Further evaluation revealed the pusher assembly was bent in multiple locations throughout its length.This damage likely occurred due to forceful advancement of the pc400 against resistance.The px slim mentioned in the complaint was not returned for evaluation.Penumbra coils and catheters 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 left internal iliac artery (iia) using penumbra coil 400''s (pc400''s).During the procedure, the physician advanced another manufacturer's angiographic catheter towards the iia and then inserted a px slim delivery microcatheter (px slim) through the angiographic catheter.The physician then opened the first pc400, soaked the coil in saline and attempted to advance it through the px slim.However, while attempting to advance the pc400 out of its introducer sheath and into the px slim, the physician advanced the coil about five centimeters from the tip of the introducer sheath and then encountered resistance.Subsequently, the pc400 was unable to advance further and was retracted.Next, the physician resoaked the pc400 in saline and made another attempt to advance the coil out of its introducer sheath and into the px slim.However, resistance was encountered again and the pc400 would not advance at all.The physician then attempted to advance the coil with force and inadvertently kinked the pc400 pusher assembly.Therefore, the pc400 was removed and the procedure was completed using a new pc400 and the same px slim.It should be noted that the physician did not use a rotating hemostasis valve (rhv) but did flush the px slim and soaked each coil in saline prior to insertion during the procedure.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: 6199747
• Report Number: 3005168196-2016-01871
• Device Sequence Number: 730779
• Product Code: HCG
• UDI-Device Identifier: 00814548010526
• UDI-Public: 00814548010526
• 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): 11/30/2016

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: 12/01/2023
• Device Catalogue Number: 4002C0620
• Device Lot Number: F66780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1