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

Model Number	IPN000074
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11787177
• Report Number: 3010532612-2021-00136
• Device Sequence Number: 14361167
• Product Code: DYG
• UDI-Device Identifier: 00801902002884
• UDI-Public: 00801902002884
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN000074
• Device Catalogue Number: AI-07127
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1