MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER KITS

Catalog Number 06597053

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

An end user reported an issue with a stf 5f m.I.Kit 45cm nt/t echo s kit.A patient presented for a diagnostic heart catheterization for an aortic valve surgery work up.The right heart catheterization and coronary angiograms were completed.The cardiologist crossed the aortic valve with straight wire and 5fr al1 catheter, and then exchanged it for a langston catheter.The left ventricle and aortic pressures were obtained, at which time the waveforms appeared to dampen.The transducers were troubleshooted by the cardiologist and scrub tech.A repeat nibp cycled and it was noted to be lower than baseline.Pressors were started and an echo was ordered.Ct surgery was notified and the patient was prepped for pericardiocentesis.While getting access, the micropuncture wire broke off in the body.Ct surgery was consulted by the cardiologist.Pericariocentresis was done with 200cc sanguinous output.The patient was taken to cpu with ccu rn to be taken for surgery when cvor was available.

Manufacturer Narrative

The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

The customer's reported complaint description of guidewire tip detached inside patient cannot be confirmed.No guidewire sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.(b)(6) was sent to guidewire supplier/manufacturer, heraeus medical for awareness of this event and dhr review of supplier lot numbers.Heraeus confirmed no internal non-conformance reports were found regarding batch in question and personnel were properly trained.This event cannot be confirmed to be a manufacturing issue.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statements: intended use the micro access kit is used for percutaneous introduction of a guidewire or catheter into the vascular system following a small 21-gauge needle stick.Potential complications: perforation of a vessel or viscus; laceration of a vessel or viscus; embolism.Instructions for use: 1.Gain percutaneous access with the 21 gauge needle.2.Advance the 0.018" guidewire through the 21 gauge needle.3.Withdraw the entry needle while leaving the 0.018" guidewire in place.4.Advance the micro-introducer over the 0.018" guidewire.5.Remove the 0.018" guidewire and the micro-introducer inner dilator.6.Advance up to a 0.038" guidewire or catheter through the microintroducer sheath.7.Remove micro-introducer sheath.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: MICRO-INTRODUCER KITS
• Type of Device: MICRO-INTRODUCER KITS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16662526
• MDR Text Key: 312603358
• Report Number: 1319211-2023-00017
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: H787065970535
• UDI-Public: H787065970535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06597053
• Device Lot Number: 5768592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female