MAUDE Adverse Event Report: ANGIODYNAMICS MICRO-INTRODUCER KITS

Catalog Number UNKNOWN

Device Problem Protective Measures Problem (3015)

Patient Problem Laceration(s) (1946)

Event Date 01/01/2022

Event Type  malfunction  

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).For each of the three events, reference reports: event 1: (b)(4) 1319211-2022-00006, event 2: (b)(4) 1319211-2022-00007 and event 3: (b)(4) 1319211-2022-00008.

Event Description

Incident 3 of 3: a charge nurse at the reporting facility reported three incidents of scalpel injuries while using microintroducer kits.In the third incident, it was reported that during a procedure, before the scalpel had been used on the patient, a nurse was cut/injured with the scalpel.It was reported that the users were experiencing issues where the blade tip does not fully retract into the scalpel sheath when the retraction mechanism was engaged.There was no report of the nurse experiencing any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of user injury due to safety scalpel cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A notification of event scar004520 was sent to microintroducer kit manufacturer galt medical as notification/awareness of the scalpel malfunction (safety feature) that resulted in end user injury.There was no reported lot number and no reported upn, only product description of microintroducer set containing scalpel.A ship history report (shr) for this customer was generated for the past 12 months and determine they only received one microintroducer upn, h965459161.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.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).For each of the three events, reference reports: event 1: (b)(4) 1319211-2022-00006, event 2: (b)(4) 1319211-2022-00007, and event 3: (b)(4) 1319211-2022-00008.

• 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 ; 5086587805
• MDR Report Key: 13505945
• MDR Text Key: 286605485
• Report Number: 1319211-2022-00008
• Device Sequence Number: 1
• Product Code: DQT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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