MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.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 an ultrathane mac-loc locking loop biliary drainage catheter was used in an unknown patient during a drainage procedure.As reported, the user stated the drainage catheter "cannot be pushed till the end on the normal inner canula (the flexible stiffener); it is possible to advance on the wire but cannot be removed; risk of breaking it." as reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information clarifying the device issue has been requested but is currently unavailable.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, cook received a complaint for a similar product experiencing the same failure mode.The physical examination of the device from the similar complaint found that the device was manufactured within specification, but that a kink was noted in the flexible stiffener.The investigation concluded that the event was due to procedural technique.Because of the similarities in the devices of the two complaints and failure modes, it is possible that the same factors caused the failure.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record for the complaint lot and related subassembly lots was also reviewed.The dhr records no nonconformances relevant to the reported failure mode.A database search of complaint history for the reported lot found no additional complaints from the field.Due to the above information, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Based on the information provided, no returned product and the results of the investigation, it was concluded that a component failure without design or manufacturing issue contributed to the failure mode.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.

Manufacturer Narrative

B5- information received 08sep2019 stated that the device was used in a biliary drainage procedure using seldinger technique.It was reported when preparing the product on the table "it was noticed that with the blue plastic canula it was not possible to totally go through the drainage catheter; still 4 to 5 cm were loose." the wire was still advanced and "it created a lot of friction and very difficult to retrieve." the catheter was removed from the patient.Another replacement device experienced the same failure.A third device of the same kind was used successfully with the metal cannula.It should be noted that medwatch report #1820334-2019-01961 and medwatch report #1820334-2019-01960 were originally submitted to capture different events at the same hospital experiencing the same failure mode.Included in the information received on 08sep2019, the reporter clarified that only two devices, same lot, failed during the same procedure on the same patient.All additional information regarding this event will be captured under this report, medwatch report #1820334-2019-01962.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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8873725
• MDR Text Key: 154026712
• Report Number: 1820334-2019-01962
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220611(10)9803570
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9803570
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1