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

Model Number	SPR2512W
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photo image analysis: product labelling identifies the device as a 2.5 x 12mm sprinter otw device but the print on the bifurcate of the device or the product lot number cannot be confirmed from the photo.Product analysis: device returned with a cut to the proximal shaft approx 1 cm distal of the strain relief, which separated the luer and the strain relief from the rest of the device.The material on both sides of the cut site was straight and even, characteristic of a cut using a sharp instrument.The outer shaft was stretched.The balloon had not been inflated.Deformation was evident to the distal tip.A guide wire was loaded through distal section of the cut device with no issues noted.It was not possible to load a guide wire through the luer and inner member tail, due to bunching of the inner member tail.The sterile pouch returned for analysis.The lot number 222066656 and the device size 2.5mm x 12mm on the label of the sterile sleeve match what was reported in the complaint file.The lot number 222066656 and the device size 2.25mm x 12mm printed on the luer did not match what was reported in the complaint file and what was on the pouch label.Balloon inflation without a luer was performed.The balloon inflated and balloon od measurements were taken using a hand held snap gauge.Measurements confirmed the device diameter as 2.5mm.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An attempt was made to use a sprinter otw ptca balloon catheter in a severely calcified lesion in the right superficial femoral artery and the right common femoral artery (sfa/cfa) with 100% stenosis for sfa and 85% stenosis for cfa.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with issues.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the sprinter otw device was back loaded with a 0.014¿ wire without any issues.When the wire was exchanged, it came out ok however the next wire used would not advance.The balloon catheter had to be cut to remove the guidewire.After the procedure the product was reviewed to determine why the wire would not pass through and found that the balloon was a 2.25 x12mm, the packaging detailed a 2.5 x x12mm device.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: annex c and annex d codes added recall ticked (h7) and correction number added (h9).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.
Additional Manufacturer Narrative
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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14632446
• Report Number: 9612164-2022-02161
• Device Sequence Number: 12241822
• Product Code: LOX
• UDI-Device Identifier: 00643169850491
• UDI-Public: 00643169850491
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P790017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2022

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: 04/13/2023
• Device Model Number: SPR2512W
• Device Catalogue Number: SPR2512W
• Device Lot Number: 222066656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 08/01/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/08/2022; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1483-2022
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 100 KG