MAUDE Adverse Event Report: COOK INC ONE-PART PERCUTANEOUS ENTRY NEEDLE; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that the hub cracked during a right buttock sclerotherapy of a venous malformation procedure.The treatment had to be changed.A clot was created at the site of the first needle and access was created with another needle to reduce the return of blood and medicine.No unintended section of the device remains inside the patient¿s body.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The one-part percutaneous entry needle was returned for evaluation.Visual inspection noted a "u" shape crack in the hub.The crack height measured 7 millimeters (mm).No other damage was noted.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the available information and the investigation findings, a definitive root cause could be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6498072
• Report Number: 1820334-2017-00795
• Device Sequence Number: 1170736
• Product Code: DYB
• UDI-Device Identifier: 00827002074118
• UDI-Public: (01)00827002074118(17)211110(10)7434837
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: SDN-21-7.0-U
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 06/05/2017
• 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: Other
• Patient Age: 13 YR
• Patient Weight: 72