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

Model Number CB1415030040OTW

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a chocolate pta balloon with a non-medtronic inflation device during treatment of a 170mm calcified lesion in the patient¿s mid right superficial femoral artery (sfa).Slight vessel tortuosity and severe calcification are reported.Artery diameter reported as 6mm.Lesion exhibited 95% stenosis.No damage was noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.Resistance was reported when advancing the device, but no excessive force was used.It is reported when the device was removed from the patient that the cage had dislodged and migrated distally (forward) on the balloon.The procedure was completed with a drug coated balloon.No patient injury reported.

Manufacturer Narrative

Additional information: the cage remained attached to the balloon during removal attempt and the device was removed from the patient without difficulty or intervention.All components of the device were accounted for.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.

Manufacturer Narrative

Device evaluation the chocolate pta balloon catheter was received covered in procedural biological sanguine residue.The balloon chamber material was in a post-inflation profile, (e.G.Not tightly wrapped nor winged).The constraining structure remained bonded at both the distal and proximal ends of the balloon chamber.The constraining structure remained centered over the balloon chamber.The distal legs of the constraining structure cell appear to be elongated.Given the directionality of the elongation the legs appear to have been pulled distally.No dislodgement of the constraining structure was noted.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: CHOCOLATE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10777089
• MDR Text Key: 214392812
• Report Number: 2183870-2020-00354
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000240387
• UDI-Public: 00763000240387
• Combination Product (y/n): N
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: CB1415030040OTW
• Device Catalogue Number: CB1415030040OTW
• Device Lot Number: B1649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 80