MAUDE Adverse Event Report: COOK INC DILATOR; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient was undergoing an unspecified implant procedure using a dilator.The tip of the dilator reportedly broke off while inserting the device over a wire.The portion of the broken tip was retrieved.No further event details were provided.Additional information was requested relating to the device handling and patient outcome.The device is available for evaluation.
Additional Manufacturer Narrative
Additional information: narrative: " after appointment: venous access over right femoral vein.After 8.5 f sheath access (needle, wire, sheath) the sheath has been removed and the dilator has been inserted over an amplatz wire without any problems.After removing the dilator, a 24 f guiding sheath / catheter of the valva mitralis clip system has been inserted.Here the physician noticed a radiopaque spot at the distal tip of the 24 f system.This has been the separated tip of the dilator which has been pushed forward over the wire by the 24 f system." patient outcome: "tip has been removed by sucking it over the wire into the 24 f system sheath with a syringe.After the tip has been in the sheath, the whole system (24f sheath, wire, tip) has been removed.The procedure restarted then with accessing the venous system." (b)(4).Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The complaint device and 65 unused devices were returned.The device failure analysis revealed the tip of the used device was separated, however no evidence was found to suggest the product was manufactured out of specification.All unused products were inspected and no evidence of nonconformance or damage was found.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.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control.Based on the information provided, examination of the returned complaint device and unused product, and the results of our investigation; a definitive root cause could not be determined.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: DILATOR
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6721066
• Report Number: 1820334-2017-01720
• Device Sequence Number: 13856938
• Product Code: DRE
• UDI-Device Identifier: 00827002014725
• UDI-Public: (01)00827002014725(17)200426(10)7863391
• 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): 12/08/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: JCD22.0-38-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 12/08/2017
• 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