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

Model Number	N/A
Medical Device Problem Codes	Unraveled Material (1664); Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter postal code: (b)(6).Patient code: no known impact or consequence to patient.Device code: unraveled material and failure to advance is not labeled.The event is currently under investigation.
Event or Problem Description
It was reported that after puncture, the micro-puncture access set wire guide was inserted from the subclavian vein.As it would not advance, the device was removed and found to be kinked and unraveled.Another device with the same specifications was used to complete the treatment.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, and manufacturing instructions, was 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.There is no evidence to suggest the product was not made to specifications.Based on the customer¿s testimony, it is reasonable to assume that a section of the coil caught on the introducing needle, thus causing the unravelling observed in the coil.Affixed to the wire guide protective shipping tube is a caution label that pictorially cautions against the reverse process of withdrawing the wire guide in the needle as damage may occur.We can also advise that manipulation of the wire through the needle may cause damage to the coil.However, without the complaint device, the above listed information cannot be confirmed and the root cause remains undetermined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that after puncture, the micro-puncture access set wire guide was inserted from the subclavian vein.As it would not advance, the device was removed and found to be kinked and unraveled.Another device with the same specifications was used to complete the treatment.There have been no adverse effects to the patient reported.

• Brand Name: MICROPUNCTURE ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5843005
• Report Number: 1820334-2016-00699
• Device Sequence Number: 266921
• Product Code: DYB
• UDI-Device Identifier: 00827002074101
• UDI-Public: (01)00827002074101(17)160801(10)4459490
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2016

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 Model Number: N/A
• Device Catalogue Number: MPIS-401-U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1