MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 7 FR 110 CM; CATHETER, FLOW DIRECTED

Model Number IPN000074

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This complaint was received via adverse event notification from inari medical.It was reported that during use on a patient, there was an issue with the transducer and therefore no pre pressures were recorded.Unrelated to the reported event (unable to get a pressure reading), later on in the case the patient suffered a ruptured papillary muscle and tricuspid valve injury.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The reported complaint for catheter "no pre pressures were recorded" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.The specific lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.

Event Description

This complaint was received via adverse event notification from inari medical.It was reported that during use on a patient, there was an issue with the transducer and therefore no pre pressures were recorded.Unrelated to the reported event (unable to get a pressure reading), later on in the case the patient suffered a ruptured papillary muscle and tricuspid valve injury.

• Brand Name: CATH PKGD: WEDGE 7 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11787177
• MDR Text Key: 249677106
• Report Number: 3010532612-2021-00136
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (y/n): N
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000074
• Device Catalogue Number: AI-07127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1