MAUDE Adverse Event Report: COOK INC RETRACTA DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number N/A

Device Problems Material Separation (1562); Separation Failure (2547)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a female patient required a retracta detachable embolization coil for coiling of a pulmonary arteriovenous malformation.The operator stated the coil would not detach from the delivery wire and due to fatigue, the wire broke at the junction zone.No intervention was required to remove the section of the wire or the coil.The coil remains inside the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information provided 22sep2020 stated the vessel was a right lower lobe subsegmental pulmonary artery branch.The operator stated the sheath and catheter were guided appropriately on the path from the inferior vena cava, through the right pulmonary vein, and into the target site.The coil was correctly positioned in the target site when it was attempted to be deployed.Additionally, examination of the returned device on 22sep2020 showed elongation of the delivery wire, but no evidence of separation of the wire.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

D10 ¿ product received on: 22sep2020.Investigation ¿ evaluation: provas of ogden in the united states informed cook of an incident involving a retracta detachable embolization coil.On (b)(6) 2020 during a procedure, the coil would not detach from the delivery wire.The coil was in the target vessel and in the appropriate position at the time of deployment.The vessel was a right lower lobe subsegmental pulmonary artery branch, about 5 mm.The wire broke at the junction zone and the coil remained inside the patient¿s body.The patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned one used device to cook for investigation.Physical examination of the returned device showed no embolization coil present.The coil on the end of the delivery wire is elongated.Due to the state of the returned device, no measurements could be taken.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for tensile strength for the bond strength of the hub/catheter shaft and material transitions.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: device description: "the retracta detachable embolization coil is designed to be delivered under fluoroscopy to the target vessel." instructions for use: "6.Under fluoroscopic visualization, slowly advance the delivery wire until the entire length of the coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.Note: if significant resistance is encountered during coil advancement, do not continue advancing.Retract the delivery wire slightly, then gently re-advance it.If there is still significant resistance, withdraw the delivery wire from the catheter and try using a new coil with a shorter length.Note: do not turn the delivery wire counterclockwise during advancement; the coil may be unintentionally detached.7.Verify correct position of the coil fluoroscopically.If coil position or placement is not satisfactory, the coil may be retracted into the catheter and re-deployed so long as there is no significant resistance.Note: it may be possible to perform a test injection of contrast media using a tuohy-borst sidearm adapter while the delivery wire is in the catheter.Note: if the size of the coil is not correct, gently remove the entire delivery wire and coil.Do not use the coil again.8.If the coil position is correct, use the torque device to turn the delivery wire counterclockwise 8-10 times, until coil detachment can be either felt or visualized under fluoroscopy.Note: it is recommended that the junction remain just inside the tip of the catheter.Note: do not advance the delivery wire after coil detachment." a review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lot record no non-conformances.A database search was completed on the complaint lot and no additional complaints were found.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no non-conformances and no additional complaints from the same lot, it was concluded that there is no evidence that nonconforming product exists in house or in field.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.The ifu states ¿under fluoroscopic visualization, slowly advance the delivery wire until the entire length of the coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.¿ it is possible the delivery wire was not advanced slowly and may have caused damage to the device, so the coil could not be easily detached.It is unknown if the connection, or junction, between the embolization coil and the delivery wire was within the catheter during attempted deployment, as advised in the ifu.If this connection zone was outside of the catheter, deployment of the coil could become more difficult.Based on the information provided, examination of the returned product, and the results of the investigation, the cause is traced to a component failure unrelated to manufacturing or design deficiencies.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: RETRACTA DETACHABLE EMBOLIZATION COIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10484877
• MDR Text Key: 205375266
• Report Number: 1820334-2020-01618
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10827002341880
• UDI-Public: (01)10827002341880(17)241216(10)10198961
• Combination Product (y/n): N
• PMA/PMN Number: K151676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MWCER-35-7-6
• Device Lot Number: 10198961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK NESTER COILS; COOK TORNADO COILS; COOK NESTER COILS; COOK TORNADO COILS
• Patient Outcome(s): Other
• Patient Age: 29 YR