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

Catalog Number	RBYPODJ30
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
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 a pod packing coil (podj).During the procedure, the physician successfully placed a ruby coil in the target vessel using a non-penumbra microcatheter.While attempting to advance a new podj, the physician noticed it became loose and unintentionally detached in the vein.Subsequently, the physician placed another coil behind the detached podj using the same microcatheter and completed the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pull tube was retracted on the proximal end of the pusher assembly and the pet lock had slid proximal on the pusher assembly hypotube.The pet step down from hypotube to pull tube was present indicating the pet was sufficiently heated onto the proximal end.Bends and kinks were present from approximately 51.0 ¿ 83.0 and 142.5 cm from the proximal end of the pusher assembly.The pull wire was retracted into the pusher assembly.The hypotube outer diameter (od) was measured and was found to be within specification.During functional testing, the pet on the hypotube was gripped and retracted resulting in the remaining pet sliding off of the hypotube.Conclusion: evaluation of the returned pusher assembly revealed the pull tube was retracted and the pet lock had slipped proximal on the hypotube.If the pull tube is retracted, the pull wire will retract from the pusher assembly ddt and the embolization coil will become detached.This was likely the cause of the reported detachment.The pet step down from hypotube to pull tube was present indicating the pet was heated onto the proximal end and the hypotube was measured to be within specification; therefore, the root cause of the pet lock slipping proximal on the hypotube could not be determined.Penumbra coils 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.

• Brand Name: POD PACKING COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8574476
• Report Number: 3005168196-2019-00850
• Device Sequence Number: 2494893
• Product Code: HCG
• UDI-Device Identifier: 00814548016719
• UDI-Public: 00814548016719
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• PMA/510(K) Number: K141134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019
• 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 Catalogue Number: RBYPODJ30
• Device Lot Number: F86475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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