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

Catalog Number	4002C0830
Medical Device Problem Codes	Detachment Of Device Component (1104); Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coils 400 (pc400).During the procedure, the physician experienced resistance while advancing a pc400 through another manufacturer's microcatheter.Consequently, the pc400 became kinked and unintentionally detached inside the patient's body.The physician required a snare device to retrieve the detached coil.The physician subsequently halted the procedure and postponed it until the following week.It should be noted that the physician used a rotating hemostasis valve (rhv); however, continuous flush was not maintained.The subsequent procedure was successfully completed using pc400, pod coils and another manufacturer's microcatheter.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using penumbra coils 400 (pc400).During the procedure, the physician experienced resistance while advancing a pc400 through another manufacturer¿s microcatheter.Consequently, the pc400 became kinked and unintentionally detached inside the patient¿s body.The physician required a snare device to retrieve the detached coil.The physician subsequently halted the procedure and postponed it until the following week.It should be noted that the physician used a rotating hemostasis valve (rhv); however, continuous flush was not maintained.The subsequent procedure was successfully completed using pc400, pod coils and another manufacturer''s microcatheter.There was no report of an adverse effect to the patient.Additional information was received on 2016-09-27 stating that the postponed procedure was successfully completed using several pc400 coils and a pod coil, with another manufacturer''s microcatheter.The outcome for the patient was positive, there were no device related issues noted and there was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2016-01386.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5983915
• Report Number: 3005168196-2016-01386
• Device Sequence Number: 13473058
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• Combination Product (Y/N): Y
• 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): 08/31/2016
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/08/2022
• Device Catalogue Number: 4002C0830
• Device Lot Number: F43892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/31/2016
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100
• Date Report Sent to FDA: 01/01/2005