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

Model Number RBYPODJ60-A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00654.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pcs), ruby coils, and a lantern delivery microcatheter (lantern).It was noted that the patient's anatomy was tortuous and calcified.During the procedure, two ruby coils were implanted into the target vessel using the lantern.Upon advancement of a pod pc through the distal end of the lantern, the physician encountered resistance.During withdrawal of the pod pc, it unintentionally detached within the lantern.Therefore, the lantern and pod pc were removed from the patient's body and the pod pc was extracted from the lantern.Next, the physician re-inserted the lantern and implanted a total of fourteen ruby coils and pod pcs.When the next pod pc was approximately half-way into the target vessel, the physician encountered resistance and subsequently, the pusher assembly broke off.Subsequently, the pod pc and lantern were removed together.The procedure was completed using three additional ruby coils, one other coil, 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 internal iliac artery (iia) using pod packing coils (pod pcs), ruby coils, and a lantern delivery microcatheter (lantern).It was noted that the patient''s anatomy was tortuous and calcified.During the procedure, two ruby coils were implanted into the target vessel using the lantern.Upon advancement of a pod pc through the distal end of the lantern, the physician encountered resistance.During withdrawal of the pod pc, it unintentionally detached within the lantern.Therefore, the lantern and pod pc were removed from the patient''s body and the pod pc was extracted from the lantern.Next, the physician re-inserted the lantern and implanted a total of fourteen ruby coils and pod pcs.When the next pod pc was approximately half-way into the target vessel, the physician encountered resistance and subsequently, the pusher assembly broke.Subsequently, the pod pc and lantern were removed together.The procedure was completed using three additional ruby coils, one other coil, 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: 3005168196-2020-00655.1.Section b.Box 5.Describe event or problem results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 24.5 cm from the proximal end.The embolization coil was detached from the pusher assembly inside its introducer sheath and had offset coil winds on the proximal end.Conclusions: evaluation of the first returned pod pc revealed that the pet lock was broken and retracted on the proximal end of the pusher assembly.If this occurs, the pull wire may retract out of the ddt, and the embolization coil will detach from its pusher assembly.Further evaluation of the returned pod pc revealed offset coil winds along the length of the embolization coil and a kink in the pusher assembly.If the pod pc is forcefully advanced against resistance, damage such as offset coil winds may occur.The kink may have occurred due to forceful advancement against resistance.Evaluation of the second returned pod pc confirmed that the pusher assembly was fractured.If the device is forcefully advanced against resistance, damage such as a kink and subsequently fracture may occur.Further evaluation revealed a detached embolization coil and offset coil winds.The detached embolization coil was likely a result of the pusher assembly fracture.The offset coil winds may be a result of forceful advancement against resistance no other devices associated with the complaint were returned, and therefore, the root cause of the reported resistance could not be confirmed.Penumbra coils are visually 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.This report is associated with mfr report number: 1.3005168196-2020-00654 h3 other text : placeholder.

• Brand Name: POD PACKING COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10061562
• MDR Text Key: 191124899
• Report Number: 3005168196-2020-00655
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017679
• UDI-Public: 00814548017679
• Combination Product (y/n): Y
• PMA/PMN Number: K170852
• 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: 01/01/2005,04/23/2020

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: RBYPODJ60-A
• Device Catalogue Number: RBYPODJ60
• Device Lot Number: F93270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• 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: 04/23/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1