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

Model Number	4004C0412
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400 (pc400) and a straight px slim delivery microcatheter (px slim).During the procedure, after successfully delivering one pc400, the physician advanced a new pc400 and it became stretched.The physician reported feeling no resistance prior to this damage.The px slim and stretched pc400 were removed from the patient.Although the pc400 was stretched, there was no issue reported with the px slim device.However, the physician decided to continue the procedure using a 90 degree px slim.It was later reported that the procedure was not successful and the patient's leg was still thrombosed.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly; the coil was damaged and intact with the pusher assembly.The pc400 was advanced distally through the returned px slim delivery microcatheter (px slim) and out the distal tip of the microcatheter without an issue.Conclusions: evaluation of the returned devices revealed that the embolization coil to the pc400 was damaged.The damage to the pc400 typically occurs due to improper handling during use.If the device is forcefully manipulated during use, the observed damage may occur.The initial complaint that the pc400 was stretched could not be confirmed.There was no visible damage to the px slim.A 0.025inch stainless steel mandrel and the returned pc400 were introduced through the hub of px slim and each advanced distally out the distal tip of the microcatheter without an issue.Pc400s are 100% functionally tested during in-process inspection.Px slims are 100% visually inspected during in-process inspection.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 using penumbra coils 400 (pc400) and a straight px slim delivery microcatheter (px slim).During the procedure, after successfully delivering one pc400, the physician advanced a new pc400 and it became stretched.The physician reported feeling no resistance prior to this damage.The px slim and stretched pc400 were removed from the patient.Although the pc400 was stretched, there was no issue reported with the px slim device.However, the physician decided to continue the procedure using a 90 degree px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report:3005168196-2016-00503.Section b.Box 5.Describe event or problem; section d.Box 5.Operator of device.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5588036
• Report Number: 3005168196-2016-00503
• Device Sequence Number: 974064
• Product Code: HCG
• UDI-Device Identifier: 00814548010847
• UDI-Public: 00814548010847
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2016
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 4004C0412
• Device Catalogue Number: 4004C0412
• Device Lot Number: F66758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided; 01/14/2005
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 06/01/2016; 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005