MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; CATHETER, FLOW DIRECTED

Catalog Number AI-07126

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via the medicines and healthcare products regulatory agency that a device was inserted during a heart cath and upon removal of the balloon wedge catheter from/through the sheath the operator felt resistance during withdrawal.It was apparent that balloon was not on the catheter.It appeared to have been stripped off in the sheath.Screening of the patient did not demonstrate any obvious foreign object.Possibly at lower right lung, not obvious with patient either.Patient stable post procedure, no obvious injury or adverse consequence.Likely caused balloon to pull off while being withdrawn through sheath.As reported the patient did not require any treatment.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint that the balloon became detached from the catheter is not able to be confirmed.The root cause of the complaint is undetermined.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported via the medicines and healthcare products regulatory agency that a device was inserted during a heart cath and upon removal of the balloon wedge catheter from/through the sheath the operator felt resistance during withdrawal.It was apparent that balloon was not on the catheter.It appeared to have been stripped off in the sheath.Screening of the patient did not demonstrate any obvious foreign object.Possibly at lower right lung, not obvious with patient either.Patient stable post procedure, no obvious injury or adverse consequence.Likely caused balloon to pull off while being withdrawn through sheath.As reported the patient did not require any treatment.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7034814
• MDR Text Key: 92153716
• Report Number: 1219856-2017-00293
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K892530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AI-07126
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00801902002877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• 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