MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER OTW; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number SPR2506W

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Injury (2348); Insufficient Information (4580)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A sprinter otw ptca balloon catheter was used during a procedure.There was no issue removing the device from the hoop.Negative prep was not performed.The device did not pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used.It was reported that nine days after the procedure the patient had ohca.Emergency cag showed an obstruction in the lad.Oct revealed a tube-like structure.Control angiography 5 days later showed persistent image despite antithrombotic therapy.The patient went for surgery (morrow procedure) due to sever residual lvot obstruction.In that surgical procedure the surgeon removed the sleeve in the lad, which explains the image and clinical follow-up after the initial alcohol ablation.Standard procedure about unwrapping the device was not followed.Therefore sleeve may not have been removed.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: one still image of the sheath of a device was provided by the account.There were no images provided showing the removal of the sheath from the patient.Angiographic images were also provided for review.The images confirm lesions in the lad and septal branch.The vessel was wired and a balloon was delivered.The proximal section of the balloon contains contrast and appears inflated.The image suggests that there is air in the mid to distal section of the balloon and therefore there is not contrast in the entire balloon.Upon removal of the balloon, there appeared to be poor flow through the vessel.There appears to be a white shadow in the lad.This appears to be most likely the sheath that was left in the vessel post removal of the balloon.The final angiographic image provided showed a pacing lead applied to the vessel.There were no images provided showing the successful treatment of the left coronary system.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

Additional info: it was stated that the procedure was a septal branch occlusion for alcohol ablation.The person preparing the balloon was experienced/ trained in preparation of balloon catheters.The balloon was pressurized at the target lesion site.The physician observed the inflation of the balloon when pressurised at the lesion site.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

Additional information: it was later indicated that the removal of the stylette and sheath did not conform to the ifu.The balloon was pressurized at the target lesion site to 6atm.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: SPRINTER OTW
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10605587
• MDR Text Key: 209136314
• Report Number: 9612164-2020-03697
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2020

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 Model Number: SPR2506W
• Device Catalogue Number: SPR2506W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 10/20/2020; 12/15/2020
• Supplement Dates FDA Received: 10/12/2020; 11/02/2020; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 67