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

Catalog Number CB1413540080OTW

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician attempted to use a chocolate pta balloon during treatment of a highly calcified lesion in the in-stent restenosis (isr) of the drug eluting stent (des) within the patient¿s proximal popliteal artery.Severe vessel calcification and tortuosity are reported.There were no issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The device was passed through a previously deployed stent.Resistance was noted during advancement.Delivery of the device is reported to have been difficult.Removal was performed once, and expansion was performed with a non-medtronic balloon prior to the chocolate balloon being used.Difficulty was encountered when attempting to remove the balloon from inside the stent.Force was applied back and forth but the device did not move.The device was pulled out by force with damage to the nitinol cage noted.A surgical cutdown was performed to complete the procedure.No further injury reported.

Manufacturer Narrative

Additional information: deflation of balloon was quite slow.Vessel damage was noted following removal.The procedure was changed to cutdown because balloon catheter was caught before pulling it out of the sheath.It became a surgical treatment and changed to vascular surgery.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 a visual inspection of the device found that the cage connector struts were broken at proximal end.The cage has been bunched at the distal end of the balloon.Due to the condition of the returned device no functional testing could be carried out.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: 11641902
• MDR Text Key: 244667461
• Report Number: 2183870-2021-00137
• Device Sequence Number: 1
• Product Code: LIT
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: CB1413540080OTW
• Device Lot Number: B3341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 04/13/2021; 05/06/2021
• Supplement Dates FDA Received: 04/19/2021; 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention