MAUDE Adverse Event Report: MEDTRONIC, INC INPUT TS INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	051102A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Tissue Injury (4559)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure, an attempt was made to use one 5 french input introducer to treat a lesion.There was no damage noted to the packaging.The device was removed from packaging and prepped per ifu with no issues noted.The device was inspected with no issues noted.Excessive force was not used during insertion/delivery.It was reported that a leak occurred.It was stated that the introducer was leaking, leading to an extensive hematoma on the patient's leg.Although the hospitalization care was extended no intervention was reported and the hematoma was only temporary.
Additional Manufacturer Narrative
Additional information: annex d, annex g codes added correction: pma/510(k) # updated 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: INPUT TS INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 11790975
• Report Number: 1220452-2021-00018
• Device Sequence Number: 19800582
• Product Code: DYB
• UDI-Device Identifier: 00643169014442
• UDI-Public: 00643169014442
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K955785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: 051102A
• Device Catalogue Number: 051102A
• Device Lot Number: 51036564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization