MAUDE Adverse Event Report: FLEXOR ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KCFW-4.0-18/35-45-RB-ANL0-HC
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The information received indicated there was difficulty withdrawing a 7mm x 4cm angioplasty balloon back into the sheath.The procedure was a contralateral approach for angioplasty of the superficial femoral and iliac arteries.The representative indicated that the patient had smaller arteries to navigate and there was a tight bifurcation.It was reported that after the balloon was inflated it would not come back into the sheath.The sheath seemed kinked and the braiding looked unusual.The sheath then had to be completely removed with the balloon hanging at the end of the sheath.No part of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence; however, the groin had to be pressed for a longer period of time because the balloon was unprotected by the sheath as it came out of the body.There were no other adverse effects to the patient reported due to this occurrence.Additionally, device images depicted stretching and elongation in regard to the sheath.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• MDR Report Key: 6572254
• Report Number: 1820334-2017-01209
• Device Sequence Number: 16172762
• Product Code: DYB
• UDI-Device Identifier: 00827002481862
• UDI-Public: (01)00827002481862(17)150301(10)3248117
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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: KCFW-4.0-18/35-45-RB-ANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PASSEO 18 BALLOON CATHETERTERUMO .018 GLIDE WIRE
• Patient Weight: 70