MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	A14BX040040170
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a physician was attempting to use a rapidcross dilation balloon to treat a lesion in the prox peroneal artery with severe calcification and 80% stenosis in a patient.A non-medtronic (viper wire) was used.No damage noted to packaging, i.E.Shelf carton, hoop/tray, no issues noted when removing the device from the hoop/tray, device was prepped per the ifu with no issues noted.It was reported that device or component detached, cracked, or fractured occurred; the device detached at hub of sheath upon removal.Small portion was hanging out of the sheath, so the physician was able to grab and remove it.Device did not pass through a previously-deployed stent, resistance was not encountered when advancing the device, excessive force was not used.No patient injury reported for this event.
Additional Manufacturer Narrative
Device evaluation: the rapidcross was removed from the box and inspected.It was discovered the catheter was fractured and separated into two segments.The rapidcross catheter was separated at the mouth/proximal end of the guidewire lumen rapid exchange port.The distal segment was approximately 34cm long.The balloon was in a post-inflated state.No damage to the distal tip was noted.The blue guidewire lumen remained intact.The fracture face was consistent with a tensile and torsional separation.The proximal segment showed the support wire outside of the green shaft approximately 10 cm.The working length of the green catheter segment was 137cm.The fracture face of the green catheter was consistent with a tensile and torsional separation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8393992
• Report Number: 2183870-2019-00118
• Device Sequence Number: 344795
• Product Code: LIT
• UDI-Device Identifier: 00821684067840
• UDI-Public: 00821684067840
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K130911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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 Expiration Date: 07/08/2019
• Device Catalogue Number: A14BX040040170
• Device Lot Number: A307191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR