MAUDE Adverse Event Report: COOK INC MEDIUM PRESSURE CONNECTING TUBE

Model Number G00040

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Per the initial reporter, it is unknown if the device will be returned.Common name & product code = dtl adaptor, stopcock, manifold, fitting, cardiopulmonary bypass.(b)(6).Pma/510(k) number = exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure involving placement of an aortic stent, a medium pressure connecting tube split.The tubing was connected and used at 750 psi at which time it split and sprayed the sterile field and occupants with contrast.Two other devices of the same type malfunctioned in the same manner during the procedure.These events are reported under patient identifiers (b)(6) and (b)(6); although they involve the same patient and same procedure.A fourth device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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 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

Additional information was received 10nov2019.The customer reported that their injector was malfunctioning, and the issue was not with the originally reported cook device associated with this complaint.The customer has had the unknown manufacturer's injector serviced and there have been no further problems with the tubing.

Manufacturer Narrative

Intial report: as reported, during a procedure involving placement of an aortic stent, a medium pressure connecting tube split.The tubing was connected and used at 750 psi at which time it split and sprayed the sterile field and occupants with contrast.Two other devices of the same type malfunctioned in the same manner during the procedure.These events are reported under patient identifiers (b)(6); although they involve the same patient and same procedure.A fourth device of the same type was used to complete the procedure.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, and quality control procedures of the device were 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.The evidence indicates the product was made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Labeling is provided with this device, which states ¿the accepted pressure rate for the connecting tube and is not to exceed 800 psi.¿ per the customer, the injector used during the event needed servicing, and it is unknown if the equipment operated above or below the maximum psi when the connecting tubes were used.Accordingly, a root conclusion could not be drawn.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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

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

• Brand Name: MEDIUM PRESSURE CONNECTING TUBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9280650
• MDR Text Key: 176799004
• Report Number: 1820334-2019-02789
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00827002000407
• UDI-Public: (01)00827002000407(17)220808(10)9937490
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: G00040
• Device Catalogue Number: DPT9.5-180-P-FM
• Device Lot Number: 9937490
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1