MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A micropuncture transitionless access set was used in a right lower extremity intervention.It was reported that, the micropuncture set was used to gain left groin access and then wire was inserted.The physician was not sure if the wire was within the lumen and pulled out the wire.During fluoroscopy, the wire was observed to have sheared off.The needle was removed and pressure was held on the groin to close the needle hole.Right groin access was gained in order to retrieve the piece of wire that sheared off using a snare.As the physician was unable to complete the intended procedure, the patient will return in approximately two weeks.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used wire guide from the micropuncture transitionless access set was returned for investigation.Visual examination showed the wire guide distal weld was missing and device coil was elongated.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6834107
• Report Number: 1820334-2017-02765
• Device Sequence Number: 13467862
• Product Code: DYB
• UDI-Device Identifier: 00827002562028
• UDI-Public: (01)00827002562028(17)200601(10)7957863
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-502-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention