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

Model Number RBYPOD12-A

Device Problems Break (1069); Stretched (1601); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using pod coils, pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil approximately 10 centimeters into the lantern, the physician experienced resistance; therefore, the pod coil was removed and flushed.The physician then attempted to re-advance the pod coil through the lantern; however, the same issue occurred.Subsequently, 12 millimeters from the proximal end of the pusher assembly of the pod coil that had not yet advanced through the lantern stretched; therefore, the pod coil was removed.The procedure was completed using a pod coil, three pod pcs and the same lantern.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using pod coils, pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).During the procedure, while advancing the pod coil approximately 10 centimeters into the lantern, the physician experienced resistance; therefore, the pod coil was removed and flushed.The physician then attempted to re-advance the pod coil through the lantern; however, the same issue occurred.Subsequently, 12 millimeters from the proximal end of the pusher assembly of the pod coil stretched and the pusher assembly broke outside of the patient prior to advancing through lantern.Therefore, the pod coil was removed.It was reported that the pusher assembly broke but remained intact.The procedure was completed using a pod coil, three pod pcs and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-00562 1.Section h.Box 5.Describe event or problem, please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2020-00562 1.Section h.Box 6.Device code 3.Results: the pet lock was intact on the proximal end of the pusher assembly.Kinks and bends were present along the length of the pusher assembly.The pusher assembly was fractured approximately 60.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and had offset coil winds at its proximal end.The proximal constraint sphere was intact with the embolization coil.Conclusions: evaluation of the returned pod12 confirmed a pusher assembly fractured and revealed offset coil winds at the proximal end of its embolization coil.If the device is manipulated against resistance, damages such as these may occur.The lantern used in the procedure was not returned for evaluation; therefore, the root cause of the resistance was unable to be determined.Further evaluation revealed that the embolization coil was detached due to the pusher assembly fracture, and the pusher assembly was kinked and bent due to the mishandling during packaging for return.These damages were likely incidental to the complaint.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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9967700
• MDR Text Key: 187924728
• Report Number: 3005168196-2020-00562
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019666
• UDI-Public: 00814548019666
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/24/2020

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
• Device Operator: Health Professional
• Device Model Number: RBYPOD12-A
• Device Catalogue Number: RBYPOD12
• Device Lot Number: F85451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1