MAUDE Adverse Event Report: COOK INC COOK TPN DOUBLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Catalog Number C-RHCD-7.0

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 05/08/2021

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that difficulty was experienced sliding the "cylindrical sleeve" of an unknown cook tpn catheter repair set into the "repair segment" as it would "not fit".As a result, the conjoined segments detached.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: b1, h6- annex a.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.

Event Description

In additional information received on 28may2021, it was reported that the procedure was a catheter repair of a tunneled-cuffed double lumen in the right internal jugular, in which the device was severed at the thin segment.The complaint device was described as a 7fr 2 lumen repair kit.It was confirmed that the device is not available for return, as it was discarded.The patient experienced bleeding and required hospitalization or prolonged hospitalization due to this occurrence.Following the failed attempt to repair the line, a peripheral iv was immediately placed.A new cvad device was then placed in a new site.The existing line had a history of repairs.A more detailed description of the failure noted that the repair segment had become dislodged.The rubberized sleeve would not advance into the glued area of the stent/segment and attempt to exert force in order to advance the sleeve would cause the glued segment to come apart.Additional details of the previous line repair are captured in another report with patient identifier: (b)(4).

Event Description

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

Manufacturer Narrative

G4 ¿ pma/510(k) #: preamendment.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

On 08may2021, (b)(6) hospital reported to cook that there are problems sliding the cylindrical sleeve into the repair segment.The complaint device was reported to be a cook tpn double lumen catheter repair set (rpn: c-rhcd-7.0, lot number unknown).The patient had a tunneled-cuffed double lumen central venous catheter (manufacturer unknown) that was placed in the internal jugular vein on an unknown date.Sometime in 2020, the catheter required a repair using the cook tpn double lumen catheter repair set (rpn: c-rhcd-7.0, lot number unknown).The repaired segment had gotten dislodged.The cook tpn double lumen catheter repair set (rpn: c-rhcd-7.0, lot number unknown) was being used to repair a device.However, the customer reported that the cylinder-shaped rubberized sleeve would not advance into the glued area of the segment to join the parts.Attempts to advance the cylinder-shaped rubberized sleeve using force caused the glued segment and stent to separate.Bleeding occurred due to the failed repair.The device was removed, and a peripheral intravenous catheter was placed.Later, the patient received a new central venous access device in a new site.The customer reported that the patient was hospitalized or required a prolonged hospitalization due to the event.The rpn was not supplied, but established as the most likely rpn based on the sales to the customer.The review of sales identified rpn: c-rhcd-7.0 to be the only repair device that is both 7 french and dual lumen that was sold to the corresponding customer.As such, the investigation was completed using the identified rpn based on this conclusion.A review of the complaint history, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.As adequate inspection activities have been established and no other lot related information is available, cook has concluded that the device was manufactured to specification and that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The device is supplied with ifu c_t_irhc_rev3, which includes accompanying imaging as well as the following information relevant to the reported failure mode: "intended use the catheter is intended for used by physicians trained and experienced in placement of central venous catheters.Standard techniques for catheter handling and repair should be employed instructions for use: prepare the area.Firmly clamp the catheter near is entrance to the skin with a rubber-shod forceps.Cut off the damaged portion of the catheter.The replacement catheter end has a preloaded metal cannula.Apply adhesive to the metal cannula.Insert the metal cannula into the existing catheter lumen with a twisting motion.Slide the exsiting catheter over the metal cannula until it is flush with the replacement catheter tubing.Apply adhesive to the junction.Slide the sleeve over the junction.Inject adhesive into both ends of the sleeve and wipe off the excessive adhesive." based on the information provided, no product returned, and the results of our investigation, a definitive root cause for this event was unable to be established.It should be noted that the glue provided with the repair kit allows for the provider to determine the amount of glue used to seal the repair segment to the device.If glue is used in excess around the junction where the metal part unifies the existing catheter lumen and the repair kit lumen, then it would make it difficult to advance the silicone sleeve over the junction.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: COOK TPN DOUBLE LUMEN CATHETER REPAIR SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11850171
• MDR Text Key: 264141477
• Report Number: 1820334-2021-01358
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-RHCD-7.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention