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

Catalog Number	MPIS-401-NT-SST
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during either a peripherally inserted central catheter (picc) or port insertion, the micropuncture transitionless access set wire guide unravelled as it was removed.The physician was able to remove the entire micropuncture transitionless access set and wire guide, and proceeded to use another set 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.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used micropuncture transitionless access set was returned with only the wire guide and needle.The wire guide was inserted through the needle, and the distal solder was not connected to the core wire.The distal end of the wire was observed to be elongated and separated from the soldered area.The length of the core was measured to be 40.2 centimeters (cm), and the overall length was 91.6 cm.The wire guide diameter was 0.01198 inches.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.There is no evidence that the product was damaged upon opening.Review of the device history record of the finished product shows two nonconforming events that could contribute to this failure mode.The affected parts were rejected.A complaint history search revealed that there were no other reported complaints for this lot number.Per labeling on the wire guide holder, "withdrawal or manipulation of distal spring coil portion of wire guide through needle tip may result in breakage and/or damage." based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.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: 7013860
• Report Number: 1820334-2017-03736
• Device Sequence Number: 944715
• Product Code: DYB
• UDI-Device Identifier: 00827002479425
• UDI-Public: (01)00827002479425(17)200703(10)8037270
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-401-NT-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1