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

Catalog Number	MPIS-401-20.0-SC-UA-082900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during an antegrade femoral access procedure, the micropuncture transitionless access set 20 sonometer cannula (lot ns8301674) fractured during an exchange (medwatch 1820334-2018-00118).The fracture occurred prior to insertion in the patient, and was easily removed off the wire guide.Another access set (micropuncture transitionless stiffened cannula access set lot 8037268) was used to successfully complete the procedure; however, the catheter accordioned and the hub separated while being pulled from the patient (refer to medwatch 1820334-2018-00119).The patient's anatomy was noted to be scarred.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The inner and outer catheters of the micropuncture transitionless access set were returned for evaluation.The nfep from the inner catheter had a segment broken off, and stretching of the nfep appeared on the distal end past the cannula.The tip of the inner catheter was present on the broken nfep tubing, and a 0.018 inch diameter wire was able to be easily advanced through the end hole.The distal end of the stainless steel tubing appeared rounded, with no defect that could have caused the nfep tubing to break.The nfep tubing appears to have stretched until it broke.The diameters of the inner and outer catheters were within specification.A slight bend was present in the inner catheter.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined; however, the root cause for this event can likely be attributed to operational/ environmental context as a bend in the stainless steel cannula could have increased friction/ resistance between the inner and outer catheters, leading to stretching of the nfep tubing.Per the quality engineering risk assessment, no further action is required.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: 7183569
• Report Number: 1820334-2018-00118
• Device Sequence Number: 1054741
• Product Code: DYB
• UDI-Device Identifier: 00827002131170
• UDI-Public: (01)00827002131170(17)201026(10)NS8301674
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-401-20.0-SC-UA-082900
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR