MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; PRESSURE MONITORING LINE

Catalog Number	H965806412421
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated for item number (h965806412421) in order to ascertain the last three lots shipped to the reporting customer in the six months prior to the procedure date.The device history records for the lots obtained through the shr (packaging lots) were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The may 2017 angiodynamics complaint report was reviewed for the pressure monitoring line product family and the failure mode "air injected." march-0, april-0 and may-0.This does not constitute an adverse trend.The used pressure monitoring line (pml) was returned to angiodynamics.As received, the pml contained bio material {blood} inside the tubing.There was no damage or manufacturing related defects noted.In addition, a microscopic inspection was performed paying particular attention to the female luer and the male luer.A microscopic visual inspection of the female was performed for any damage, and it was noted that there was a slight surface crack just below the female threads.A microscopic visual inspection of the male was performed for any damage, and it was noted that there was a slight surface crack just below the male threads.The surface cracks noted, did not extend to the inside of the fittings.The male and female tapers as well as the female threads were measured and found to be within specification.Leak testing was then performed on the device, and it passed testing.The reported complaint description cannot be confirmed as the returned sample was evaluated and was found visually, dimensional and functionally acceptable.It is possible that the end user did not fully secure the connections on each end of the pml, thereby allowing air to enter the system.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6), "during an angio procedure, images were taken on the left sided arteries.The catheter was changed, aspirated back, and tested with no issues.Once engaged into the rca, images were taken and multiple bubbles injected down artery due to crack occurring at end of extension tubing that connects to 3-way tap." it was also stated that, "the patient did not suffer any adverse effects." the used pressure monitoring line was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Common Device Name: PRESSURE MONITORING LINE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6698912
• Report Number: 1317056-2017-00051
• Device Sequence Number: 16393640
• Product Code: DRI
• UDI-Device Identifier: H965806412421
• UDI-Public: H965806412421
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: H965806412421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/10/2017
• 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: Other