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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/28/2017
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 an unspecified procedure.It was reported that, during the procedure, the introducer sheath broke off in the patient's leg.A cut down was performed to remove the device.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
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used inner and outer catheter of the micropuncture transition less access set were returned for investigation.The shaft of the outer catheter was separated.A 5 mm compression is present at the proximal end of the distal section of the shaft.Outer catheter length and diameter met specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.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.All sections of the micropuncture transitionless access set are 100% inspected and verified prior to release.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and 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: 6833945
• Report Number: 1820334-2017-02764
• Device Sequence Number: 65635
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)200315(10)7751890
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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-401-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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
• Patient Age: 89 YR