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

Model Number RBYPODJ45-A

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01751.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod packing coils, a lantern delivery microcatheter (lantern), non-penumbra catheter, and guidewire.During the procedure, the physician successfully placed multiple coils in the target vessel using the lantern, followed by a pod packing coil.Upon removal of the delivery system, the physician noticed part of the pusher assembly of the pod packing coil was missing.Subsequently, the lantern was removed, and the remaining pusher assembly was flushed out from the lantern.It was reported that the lantern did not appear to be damaged.The lantern was then flushed with saline, and an attempt was made to preload the lantern with the guidewire.While attempting to load the guidewire, the guidewire would not advance through the lantern.Therefore, the lantern was not used for the remainder of the procedure.The procedure was completed using another microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The pusher assembly was fractured approximately 58.5 cm from the proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned lantern revealed an ovalized and kinked catheter.If the lantern is forcefully mishandled during the procedure, damage such as this may occur.During the functional test, resistance was encountered due to the ovalization in the catheter shaft and the demonstration pod pc could not be advanced any further.Evaluation of the returned pod pc revealed a fractured pusher assembly.If the pod pc is forcefully mishandled during use, damage such as a kink and subsequent fracture may occur.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2020-01751.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10688705
• MDR Text Key: 211649405
• Report Number: 3005168196-2020-01752
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017662
• UDI-Public: 00814548017662
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYPODJ45-A
• Device Catalogue Number: RBYPODJ45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR