MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.The preliminary investigation results have been sent today.We will update later if any further information is determined.Investigation - evaluation a review of the dimensional verification, complaint history, drawing, manufacturing instructions, quality control, and trends was conducted during the investigation.Additionally, a functional and visual examination of unused product was performed.Three used devices from lot # 6135153 were leak tested and confirmed to leak while an 0.035 wire guide was in place.The devices all leaked from the center of the silicone disc.Additional unused devices were returned from 6135153 (quantity 10), 5964945 (quantity 1), 6031801 (quantity 6).During testing of those devices, they were confirmed for leakage.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.There are controls in place to detect leakage while in the manufacturing process, and the valve is 100% leak tested per quality control specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
As stated by the reporter: on (b)(6) 2015 during three fistula gram cases, two of the three cook sheaths used from the same lot leaked excessively.The event occurred after the physician pulled the dilator out of the sheath over a.035 glide wire (another manufacturer).This would result in a steady drip and the use of another sheath.No harm to patients.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation : functional testing of returned devices from lot # 6135153 were leak tested and leakage was confirmed (associated with fitting).The devices all leaked from the center of the silicone disc.Additionally, a document based investigation evaluation was performed.There were ten rejects for this lot during internal quality control.It is likely that manufacturing activities may have contributed to this failure.Measures have been conducted to address this failure mode.We will continue to monitor for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6530974
• Report Number: 1820334-2017-00944
• Device Sequence Number: 867035
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)180819(10)6135153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: RYCFW-6.0-35-6-RB-CW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/29/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1