MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: WEDGE 6 FR 110 CM; BALLOON WEDGE PRESSURE CATHETER PROD

Catalog Number AI-07126

Device Problems Deflation Problem (1149); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported via an email from customer service on behalf of a customer in (b)(6) that 'the balloon at the end came on and was stuck in patient.' additional information received from the charge nurse at the hospital on (b)(6) 2014: 'right heart catheterization through right femoral vein.A competitor's catheter was inserted into the distal left pulmonary artery, poor wedge.They exchanged over the 0.035' long guide wire with the arrow balloon wedge catheter.Wedged a few times in different pulmonary artery branches (2 lpa branches and 1 rpa branch), difficult to get a decent (cpwp) pulmonary capillary wedge pressure despite good radiographic occlusion.Eventually, they managed to obtain 1 pcwp trace.Balloon inflation and deflation did not behave predictably.Multiple cumulative negative pressures needed to deflate balloon on some occasions.Balloon catheter displaced during maneuvers therefore decided to remove it.Some pressure felt when removing balloon catheter through the sheath.

Manufacturer Narrative

(b)(4).Pulmonary arterial hypertension.The (la) left atrial pressure not significantly elevated.Simultaneous (lv) left ventricle '(rv) right ventricle pressure through pigtail in lv did not demonstrate any significant differences.A (tr) radial artery compression device was used to assist hemostasis of the radial artery after the procedure.On examining balloon wedge catheter outside the patient, the balloon could not be found and may have detached.Mpa and right femoral sheath removed under screening, nothing radio-opaque was seen.Femoral vein sheath cut apart, but balloon not visible.They cannot be certain if balloon had embolized in the patient or fell outside the patient.They explained the equipment failure to the patient and the nurse in charge of the cath lab.The rn will report this to the device company for further investigation.' on (b)(6) 2014 information received from the customer stated 'the patient had no medical events before the procedure.Following the procedure, that evening the patient had two complications unrelated to the balloon issue, slurred speech and a thrombosis right hand (right radial puncture).' the cath lab manager stated that the patient was an inpatient so was already planned to stay in hospital.The patient was observed closely for any respiratory problems etc.We cannot confirm where the balloon is.The equipment, sheath and drapes were checked post procedure, but no balloon seen.There was no evidence of balloon under fluoroscopy inside the patient.On (b)(6) 2014 information from the md reported 'i will endeavour to answer your questions.I was the physician/operator who performed the procedure.The balloon wedge catheter did not seem to deflate predictably radio graphically; therefore i had to do 2 syringe full of deflation using the tiny syringe provided before locking the port.Prior to pulling the balloon wedge catheter out, the balloon looked completely deflated via radiographically.It's unclear what you meant by 'how long did i take to remove the catheter', but if you're requiring a time, i would think it's a gradual continuous pull which probably lasted 5-10 seconds, the same way we would remove any catheter from a patient.It's unclear what you meant by 'cut down', but if you're enquiring about cutting the femoral sheath open, we did that but couldn't find the balloon.A second wedge pressure catheter was not used.I have not viewed the initial report by nhs, but i would like to correct the statement on your replay to the complaint letter.It is important to note that we cannot confirm the balloon was 'stuck in the patient'.We could not find it on the catheter, on the floor, or the cut open femoral sheath therefore the balloon may have dislodged in the patient.

• Brand Name: CATH PKGD: WEDGE 6 FR 110 CM
• Type of Device: BALLOON WEDGE PRESSURE CATHETER PROD
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth dr; chelmsford MA 01824
• Manufacturer Contact: kathryn myers, associate ; 2400 bernville rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4339616
• MDR Text Key: 17226689
• Report Number: 3010532612-2014-00032
• 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: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/24/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F14C0075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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