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

Catalog Number	4004C0620
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked throughout its length, and the introducer sheath was full of coagulated blood and kinked 23.0 and 57.0 cm from the distal end.Some of this damage may have been due to return packaging conditions, as the pc 400 coil was folded and bent inside the packaging.The pusher assembly was fractured approximately 5.0 and 60.0 cm from the proximal end.Due to damage from return packaging conditions and coagulated blood inside the introducer sheath, the coil could not be extracted for evaluation.Conclusions: the complaint has been evaluated.The complaint indicated that during a procedure, the first pc 400 coil delivered did not create the desired casting shape.The procedure continued successfully using a new pc 400 coil.Evaluation of the returned device revealed the pusher assembly was kinked and fractured and the introducer sheath was kinked.Some of this damage may have been due to return packaging conditions, as the pc 400 coil was folded and bent inside the packaging.Due to this return packaging damage and coagulated blood in the introducer sheath, the coil could not be extracted to test its shaping ability, and the root cause of the complaint could not be determined.These devices are 100% functionally tested during process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Conclusions¿ the investigation findings do not lead to a clear conclusion about the cause of coil did not take intended shape.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a penumbra coil 400 (pc400).During the procedure, the physician noticed the pc400 was not forming and therefore, was removed.The procedure was successful using another pc400 coil.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: 8701219
• Report Number: 3005168196-2019-01172
• Device Sequence Number: 13954693
• Product Code: HCG
• UDI-Device Identifier: 00814548010892
• UDI-Public: 00814548010892
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 06/22/2015
• 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: 03/31/2020
• Device Catalogue Number: 4004C0620
• Device Lot Number: F62949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• 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: 06/22/2015
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005